Nice-Pak Products, LLC
Smyrna, TN, US
Nice-Pak Products, LLC appears in FDA device records in Smyrna, TN. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Nice-Pak Products, LLC between 1978 and 1998. The busiest year on record is 1978, with 3. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 3 |
| 1981 | 1 |
| 1983 | 1 |
| 1984 | 3 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K974768 | PDI STERILE LUBRICATING JELLY | KMJ | Substantially Equivalent | |
| K840343 | PDI PREPMASTER WET PACK VAGINAL-X21477 | KGO | Substantially Equivalent | |
| K840342 | PDI PREPMASTER WET PACK PATIENT PREP KIT | FRG | Substantially Equivalent | |
| K840344 | PDI PREPMASTER WET PACK MINOR PROCEDURE | FRG | Substantially Equivalent | |
| K833549 | PDI SURGICAL SCRUB/BRUSH T150-70 | NAB | Substantially Equivalent | |
| K810337 | PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 | GEC | Substantially Equivalent | |
| K781539 | ISO-CARE KIT | HMP | Substantially Equivalent | |
| K780279 | ICE-PAK, PDI | IMD | Substantially Equivalent | |
| K780400 | DEN-Z-ORB | KHR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1025121 | 1025121 | Nice-Pak Products, LLC | 1 Swan Dr, Smyrna, TN 37167 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
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.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Nice-Pak Products, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain