MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4— 510(k) K853216

Name: FDA 510(k) clearance K853216
Creator: U.S. Food and Drug Administration
Published: 1986-04-02

Substantially Equivalent

Gyneco, Inc.

FDA 510(k) clearance K853216 for MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4, Substantially Equivalent on 1986-04-02. Applicant: Gyneco, Inc.. Device class: 2.

Clearance details

Applicant: Gyneco, Inc.
Product code: Code HHK
Device class: Class 2
Regulation: 21 CFR 884.1175
Advisory panel: Obstetrics/Gynecology
Date received: 1985-08-01
Decision date: 1986-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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K861409 — SYNCARE TEMPORARY CARDIAC PACING WIRE1986-05-05
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K843941 — ENDOCYTE1985-02-25
K841275 — FINE NEEDLE ASPIRATION DEVICE1984-08-17

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