SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)


Device Classification Name

ring, annuloplasty

510(k) Number K022363
Device Name SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
Original Applicant
ST. JUDE MEDICAL, INC.
one lillehei plaza
st. paul, 
MN 
55117

Original Contact william mckelvy
Regulation Number 870.3800
Classification Product Code
KRH  
Date Received 07/22/2002
Decision Date 09/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No