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FDA 510(k) Application Details - K053300
Device Classification Name
Clamp, Vascular
More FDA Info for this Device
510(K) Number
K053300
Device Name
Clamp, Vascular
Applicant
MARINE POLYMER TECHNOLOGIES, INC.
107 WATER ST.
DANVERS, MA 01923 US
Other 510(k) Applications for this Company
Contact
SERGIO FINKIELSZTEIN
Other 510(k) Applications for this Contact
Regulation Number
870.4450
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Classification Product Code
DXC
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More FDA Info for this Product Code
Date Received
11/25/2005
Decision Date
03/28/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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