PROBET (TM)— 510(k) K903002

Substantially Equivalent

Gynopharma, Inc.

FDA 510(k) clearance K903002 for PROBET (TM), Substantially Equivalent on 1991-04-05. Applicant: Gynopharma, Inc.. Device class: 2.

Clearance details

Applicant: Gynopharma, Inc.
Product code: Code HFF
Device class: Class 2
Regulation: 21 CFR 884.1060
Advisory panel: Obstetrics/Gynecology
Date received: 1990-07-09
Decision date: 1991-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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