SHELHIGH BIORING


Device Classification Name

ring, annuloplasty

510(k) Number K023940
Device Name SHELHIGH BIORING
Original Applicant
SHELHIGH, INC.
650 liberty ave.
union, 
NJ 
07083

Original Contact shlomo gabbay
Regulation Number 870.3800
Classification Product Code
KRH  
Date Received 11/26/2002
Decision Date 06/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No