CARBODISSECTING ENDOSCOPE


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K013680
Device Name CARBODISSECTING ENDOSCOPE
Original Applicant
ENDO SURGICAL DEVICES, INC.
7 tiffany trail
hopkinton, 
MA 
01748

Original Contact debbie iampietro
Regulation Number 878.4400
Classification Product Code
GEI  
Subsequent Product Code
GCJ  
Date Received 11/07/2001
Decision Date 03/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No