SMI CARDIOVASCULAR PATCH


Device Classification Name

patch, pledget and intracardiac, petp, ptfe, polypropylene

510(k) Number K122105
Device Name SMI CARDIOVASCULAR PATCH
Applicant
SOLINAS MEDICAL INC
443 costa mesa terrace
sunny vale, 
CA 
94089

Applicant Contact james hong
Correspondent
SOLINAS MEDICAL INC
443 costa mesa terrace
sunny vale, 
CA 
94089

Correspodent Contact james hong
Regulation Number 870.3470
Classification Product Code
DXZ  
Date Received 07/17/2012
Decision Date 12/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No