CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX)— 510(k) K874791

Name: FDA 510(k) clearance K874791
Creator: U.S. Food and Drug Administration
Published: 1988-04-12

Substantially Equivalent

Schmid Laboratories, Inc.

FDA 510(k) clearance K874791 for CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX), Substantially Equivalent on 1988-04-12. Applicant: Schmid Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Schmid Laboratories, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1987-11-23
Decision date: 1988-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Little Falls, NJ, US

Download summary PDF View on FDA.gov ↗

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K882893 — CONDOMS (RAMSES, SHEIK AND KOROMEX)1988-10-26
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Data sourced from openFDA. This site is unofficial and independent of the FDA.