MEMO 3D SEMIRIGID ANNULOPLASTY RING

Device Classification Name

ring, annuloplasty

510(k) Number K071327
Device Name MEMO 3D SEMIRIGID ANNULOPLASTY RING
Applicant
SORIN BIOMEDICA CARDIO S.R.L.
1300 east anderson lane
austin, 
TX 
78752 -1793

Applicant Contact heather crawford
Correspondent
SORIN BIOMEDICA CARDIO S.R.L.
1300 east anderson lane
austin, 
TX 
78752 -1793

Correspodent Contact heather crawford
Regulation Number 870.3800
Classification Product Code
KRH  
Date Received 05/11/2007
Decision Date 08/10/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No