CONDOM-MATE VAGINAL LUBRICANT— 510(k) K881338

Name: FDA 510(k) clearance K881338
Creator: U.S. Food and Drug Administration
Published: 1988-05-16

Substantially Equivalent

Upsher-Smith Laboratories, Inc.

FDA 510(k) clearance K881338 for CONDOM-MATE VAGINAL LUBRICANT, Substantially Equivalent on 1988-05-16. Applicant: Upsher-Smith Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Upsher-Smith Laboratories, Inc.
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 1988-03-29
Decision date: 1988-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.