LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT— 510(k) K943989

Name: FDA 510(k) clearance K943989
Creator: U.S. Food and Drug Administration
Published: 1994-09-12

Substantially Equivalent

Gabris Surgical Corp.

FDA 510(k) clearance K943989 for LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT, Substantially Equivalent on 1994-09-12. Applicant: Gabris Surgical Corp.. Device class: 2.

Clearance details

Applicant: Gabris Surgical Corp.
Product code: Code HFO
Device class: Class 2
Regulation: 21 CFR 884.2700
Advisory panel: Obstetrics/Gynecology
Date received: 1994-08-16
Decision date: 1994-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Virginia Beach, VA, US

Download summary PDF View on FDA.gov ↗

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