TROJAN POLYURETHANE CONDOM— 510(k) K942697

Substantially Equivalent

Carter Products

FDA 510(k) clearance K942697 for TROJAN POLYURETHANE CONDOM, Substantially Equivalent on 1995-06-22. Applicant: Carter Products. Device class: 2.

Clearance details

Applicant: Carter Products
Product code: Code MOL
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1994-06-08
Decision date: 1995-06-22
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.