North American Sterilization & Packaging Co.
Sparta, NJ, US
North American Sterilization & Packaging Co. appears in FDA device records in Sparta, NJ. FDA records list 16 510(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
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for North American Sterilization & Packaging Co. between 1989 and 1997. The busiest year on record is 1990, with 5. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1990 | 5 |
| 1991 | 3 |
| 1993 | 3 |
| 1996 | 2 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964231 | NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) | KMF | Substantially Equivalent | |
| K963753 | NASP TRANSPARENT DRESSING | MGP | Substantially Equivalent | |
| K962352 | HYDROGEL SKIN DRESSING | NAE | Substantially Equivalent | |
| K925593 | NORTEC STERILE WATER FOR DEVICE IRRIGATION | LDQ | Substantially Equivalent | |
| K925588 | NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI | LDQ | Substantially Equivalent | |
| K925161 | NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO | KNY | Substantially Equivalent | |
| K911865 | NORTEC CONNECTING TUBE SET | GAZ | Substantially Equivalent | |
| K911784 | NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY | BTQ | Substantially Equivalent | |
| K910691 | NORTEC URETERAL STENT | FAD | Substantially Equivalent | |
| K903162 | FLEXIBLE ENDOSCOPIC ELECTRODES | FAS | Substantially Equivalent | |
| K903156 | CONTROL-TIP CYSTOSCOPIC ELECTRODES | FAS | Substantially Equivalent | |
| K902763 | STERILE INSTRUMENT DRAPE | HMW | Substantially Equivalent | |
| K900401 | NAS&P GRASPING FORCEPS & ASSOC. DEVICES | KOQ | Substantially Equivalent | |
| K896821 | OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE | KOQ | Substantially Equivalent | |
| K894939 | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY | FPD | Substantially Equivalent | |
| K894986 | 3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET | OCZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- KOQAdhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
- BTQAirway, Nasopharyngeal
- KMFBandage, Liquid
- HMWDrape, Microscope, Ophthalmic
- MGPDressing, Wound And Burn, Occlusive
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- FASElectrode, Electrosurgical, Active, Urological
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- FADStent, Ureteral
- FPDTube, Feeding
- GAZTubing, Noninvasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain