DUET (CONDOMS)— 510(k) K880185

Substantially Equivalent

American Laboratories, Inc.

FDA 510(k) clearance K880185 for DUET (CONDOMS), Substantially Equivalent on 1988-06-17. Applicant: American Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: American Laboratories, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1988-01-15
Decision date: 1988-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lynbrook, NY, 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.