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FDA 510(k) Application Details - K122105
Device Classification Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
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510(K) Number
K122105
Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant
SOLINAS MEDICAL INC
443 COSTA MESA TERRACE
SUNNY VALE, CA 94089 US
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Contact
JAMES HONG
Other 510(k) Applications for this Contact
Regulation Number
870.3470
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Classification Product Code
DXZ
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More FDA Info for this Product Code
Date Received
07/17/2012
Decision Date
12/07/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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