SLIMCATH (TM)— 510(k) K903001

Substantially Equivalent

Gynopharma, Inc.

FDA 510(k) clearance K903001 for SLIMCATH (TM), Substantially Equivalent on 1991-06-25. Applicant: Gynopharma, Inc.. Device class: 1.

Clearance details

Applicant: Gynopharma, Inc.
Product code: Code HIT
Device class: Class 1
Regulation: 21 CFR 886.1170
Advisory panel: Ophthalmic
Date received: 1990-07-09
Decision date: 1991-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Gynopharma, Inc.

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