SMI CARDIOVASCULAR PACH


Device Classification Name

patch, pledget and intracardiac, petp, ptfe, polypropylene

510(k) Number K112683
Device Name SMI CARDIOVASCULAR PACH
Applicant
SOLIMAS MEDICAL, INC.
443 costa mesa terrace
sunnyvale, 
CA 
94089

Applicant Contact micheal kolbe
Correspondent
SOLIMAS MEDICAL, INC.
443 costa mesa terrace
sunnyvale, 
CA 
94089

Correspodent Contact micheal kolbe
Regulation Number 870.3470
Classification Product Code
DXZ  
Date Received 09/15/2011
Decision Date 12/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No