MITRA-LIFT


Device Classification Name

ring, annuloplasty

510(k) Number K103812
Device Name MITRA-LIFT
Applicant
SCIENCITY CO., LTD
325 n. puente st.
unit b
brea, 
CA 
92821

Applicant Contact joyce bang
Correspondent
SCIENCITY CO., LTD
325 n. puente st.
unit b
brea, 
CA 
92821

Correspodent Contact joyce bang
Regulation Number 870.3800
Classification Product Code
KRH  
Date Received 12/29/2010
Decision Date 05/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No