GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP— 510(k) K852357

Name: FDA 510(k) clearance K852357
Creator: U.S. Food and Drug Administration
Published: 1985-07-05

Substantially Equivalent

Gyneco, Inc.

FDA 510(k) clearance K852357 for GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP, Substantially Equivalent on 1985-07-05. Applicant: Gyneco, Inc.. Device class: 1.

Clearance details

Applicant: Gyneco, Inc.
Product code: Code HFB
Device class: Class 1
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1985-06-03
Decision date: 1985-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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