CONTINUOUS FLOW BIOPSY PROBE— 510(k) K942626

Name: FDA 510(k) clearance K942626
Creator: U.S. Food and Drug Administration
Published: 1995-05-30

Substantially Equivalent

Gm Engineering, Inc.

FDA 510(k) clearance K942626 for CONTINUOUS FLOW BIOPSY PROBE, Substantially Equivalent on 1995-05-30. Applicant: Gm Engineering, Inc.. Device class: 2.

Clearance details

Applicant: Gm Engineering, Inc.
Product code: Code FDC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-06-02
Decision date: 1995-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Verne, CA, US

Download summary PDF View on FDA.gov ↗

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