LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT— 510(k) K944640

Name: FDA 510(k) clearance K944640
Creator: U.S. Food and Drug Administration
Published: 1994-10-11

Substantially Equivalent

Gabris Surgical Corp.

FDA 510(k) clearance K944640 for LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT, Substantially Equivalent on 1994-10-11. Applicant: Gabris Surgical Corp.. Device class: 2.

Clearance details

Applicant: Gabris Surgical Corp.
Product code: Code FBQ
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-21
Decision date: 1994-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Virginia Beach, VA, US

Download summary PDF View on FDA.gov ↗

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