INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200


Device Classification Name

colonoscope and accessories, flexible/rigid

510(k) Number K023259
Device Name INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
Original Applicant
HELIX MEDICAL, INC.
1110 mark ave.
carpinteria, 
CA 
93013

Original Contact cynthia m anderson
Regulation Number 876.1500
Classification Product Code
FDF  
Date Received 09/30/2002
Decision Date 12/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No