TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL— 510(k) K901197

Name: FDA 510(k) clearance K901197
Creator: U.S. Food and Drug Administration
Published: 1990-04-16

Substantially Equivalent

Carter Products

FDA 510(k) clearance K901197 for TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL, Substantially Equivalent on 1990-04-16. Applicant: Carter Products. Device class: 2.

Clearance details

Applicant: Carter Products
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1990-03-12
Decision date: 1990-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, 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.