R-PORT II LAPAROSCOPIC ACCESS DEVICE


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K073170
Device Name R-PORT II LAPAROSCOPIC ACCESS DEVICE
Applicant
ADVANCED SURGICAL CONCEPTS
49 plain st.
north attleboro, 
MA 
02760

Applicant Contact mary mcnamara-cullinane
Correspondent
ADVANCED SURGICAL CONCEPTS
49 plain st.
north attleboro, 
MA 
02760

Correspodent Contact mary mcnamara-cullinane
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 11/09/2007
Decision Date 12/03/2007
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