GIBBONS STERILE TROCAR KITS— 510(k) K012198

Name: FDA 510(k) clearance K012198
Creator: U.S. Food and Drug Administration
Published: 2001-08-09

Substantially Equivalent

Gibbons Surgical Corp.

FDA 510(k) clearance K012198 for GIBBONS STERILE TROCAR KITS, Substantially Equivalent on 2001-08-09. Applicant: Gibbons Surgical Corp.. Device class: 2.

Clearance details

Applicant: Gibbons Surgical Corp.
Product code: Code FBQ
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 2001-07-13
Decision date: 2001-08-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Virginia Beach, VA, US

Download summary PDF View on FDA.gov ↗

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