HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)— 510(k) K991047

Name: FDA 510(k) clearance K991047
Creator: U.S. Food and Drug Administration
Published: 1999-06-18

Substantially Equivalent

Hardcover Products, Inc.

FDA 510(k) clearance K991047 for HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE), Substantially Equivalent on 1999-06-18. Applicant: Hardcover Products, Inc.. Device class: 2.

Clearance details

Applicant: Hardcover Products, Inc.
Product code: Code LTZ
Device class: Class 2
Regulation: 21 CFR 884.5310
Advisory panel: Obstetrics/Gynecology
Date received: 1999-03-30
Decision date: 1999-06-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Concord, Ontario, CA

Download summary PDF View on FDA.gov ↗

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