Contour Fabricators of Florida, Inc.
St. Petersburg, FL, US
Contour Fabricators of Florida, Inc. appears in FDA device records in St. Petersburg, FL. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Contour Fabricators of Florida, Inc. between 1993 and 1996. The busiest year on record is 1996, with 10. The most recent is 1996, with 10.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 5 |
| 1996 | 10 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K955685 | RNS STERILE, DISPOSABLE CT BIOPSY TRAY | DXT | Substantially Equivalent | |
| K962040 | RNS ARTHROGRAM TRAY | FMI | Substantially Equivalent | |
| K955687 | RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY | JAA | Substantially Equivalent | |
| K955689 | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | DWS | Substantially Equivalent | |
| K955684 | RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY | DXT | Unknown | |
| K955679 | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY | HIO | Substantially Equivalent | |
| K955688 | RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY | FRG | Substantially Equivalent | |
| K955686 | RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY | FRG | Substantially Equivalent | |
| K955678 | RNS STERILE DISPOSABLE PUNCTURE TRAY | FRG | Substantially Equivalent | |
| K955683 | RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY | MJG | Substantially Equivalent | |
| K952396 | REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION | BSY | Substantially Equivalent | |
| K952395 | REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION | BSY | Substantially Equivalent | |
| K952407 | REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER | KYZ | Substantially Equivalent | |
| K952406 | REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION | KYZ | Substantially Equivalent | |
| K952925 | READY NURSE SYSTEM (RNS) TRACH CARE KIT | LRQ | Unknown | |
| K934072 | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM | KNY | Unknown | |
| K935092 | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM | FMF | Unknown | |
| K933151 | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM | FRG | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- BSYCatheters, Suction, Tracheobronchial
- MJGDevice, Percutaneous, Biopsy
- DXTInjector And Syringe, Angiographic
- DWSInstruments, Surgical, Cardiovascular
- FMINeedle, Hypodermic, Single Lumen
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- LRQTracheostomy And Nasal Suctioning Kit
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain