TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)— 510(k) K901192

Name: FDA 510(k) clearance K901192
Creator: U.S. Food and Drug Administration
Published: 1990-04-16

Substantially Equivalent

Carter Products

FDA 510(k) clearance K901192 for TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING), 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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K912901 — TROJAN (TM-TBD) CONDOM1992-02-03
K904782 — ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST1990-12-06
K904273 — MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.1990-10-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.