TOMAC LUBRICATING JELLY— 510(k) K822143

Name: FDA 510(k) clearance K822143
Creator: U.S. Food and Drug Administration
Published: 1982-07-30

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K822143 for TOMAC LUBRICATING JELLY, Substantially Equivalent on 1982-07-30. Applicant: American Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 1982-07-21
Decision date: 1982-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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