ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.DIA. 11.5MM SHAFT ,MODEL PEL


Device Classification Name

colonoscope and accessories, flexible/rigid

510(k) Number K080317
Device Name ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.DIA. 11.5MM SHAFT ,MODEL PEL
Applicant
SYNTHEON LLC
7290 sw 42nd st.
miami, 
FL 
33155

Applicant Contact al weisenborn
Correspondent
SYNTHEON LLC
7290 sw 42nd st.
miami, 
FL 
33155

Correspodent Contact al weisenborn
Regulation Number 876.1500
Classification Product Code
FDF  
Date Received 02/06/2008
Decision Date 04/29/2008
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