ULTRA SEAL STERILE LUBRICATING JELLY— 510(k) K101522

Name: FDA 510(k) clearance K101522
Creator: U.S. Food and Drug Administration
Published: 2010-12-23

Substantially Equivalent

Ultra Seal Corporation

FDA 510(k) clearance K101522 for ULTRA SEAL STERILE LUBRICATING JELLY, Substantially Equivalent on 2010-12-23. Applicant: Ultra Seal Corporation. Device class: 1.

Clearance details

Applicant: Ultra Seal Corporation
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 2010-06-02
Decision date: 2010-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Paltz, 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.