ENDOSCOPIC PLICATION SYSTEM


Device Classification Name

endoscope and/or accessories

510(k) Number K023234
Device Name ENDOSCOPIC PLICATION SYSTEM
Original Applicant
NDO SURGICAL, INC.
125 high st.,
suite 7
mansfield, 
MA 
02048

Original Contact eric bannon
Regulation Number 876.1500
Classification Product Code
KOG  
Subsequent Product Code
GAW  
Date Received 09/27/2002
Decision Date 04/17/2003
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