PDI STERILE LUBRICATING JELLY— 510(k) K974768

Name: FDA 510(k) clearance K974768
Creator: U.S. Food and Drug Administration
Published: 1998-01-16

Substantially Equivalent

Nice-Pak Products, Inc.

FDA 510(k) clearance K974768 for PDI STERILE LUBRICATING JELLY, Substantially Equivalent on 1998-01-16. Applicant: Nice-Pak Products, Inc.. Device class: 1.

Clearance details

Applicant: Nice-Pak Products, Inc.
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 1997-12-22
Decision date: 1998-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.