CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K010789
Device Name CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
Original Applicant
A & A MEDICAL, INC.
9370 industrial trace
alpharetta, 
GA 
30004 -3383

Original Contact jihad mansour
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 03/15/2001
Decision Date 04/27/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No