OMNIPORT


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K002013
Device Name OMNIPORT
Original Applicant
ADVANCED SURGICAL CONCEPTS (ASC)
49 plain st.
north attleboro, 
MA 
02760

Original Contact mary mcnamara-cullinane
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 07/03/2000
Decision Date 09/29/2000
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