Device Classification Name ring, annuloplasty
510(k) Number K023940
Device Name SHELHIGH BIORING
Applicant
SHELHIGH, INC.
650 LIBERTY AVE.
union,  NJ  07083
Applicant Contact shlomo gabbay
Correspondent
SHELHIGH, INC.
650 LIBERTY AVE.
union,  NJ  07083
Correspondent Contact shlomo gabbay
Regulation Number870.3800
Classification Product Code
KRH  
Date Received11/26/2002
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