MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K080257
Device Name MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS
Applicant
MEDTRONIC XOMED, INC.
6743 southpoint dr. north
jacksonville, 
FL 
32216

Applicant Contact jayme wilson
Correspondent
MEDTRONIC XOMED, INC.
6743 southpoint dr. north
jacksonville, 
FL 
32216

Correspodent Contact jayme wilson
Regulation Number 876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HET  
Date Received 01/31/2008
Decision Date 05/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No