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FDA 510(k) Application Details - K070557
Device Classification Name
Dressing, Wound, Drug
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510(K) Number
K070557
Device Name
Dressing, Wound, Drug
Applicant
MARINE POLYMER TECHNOLOGIES, INC.
461 BOSTON ST., UNIT B5
TOPSFIELD, MA 01983 US
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Contact
SERGIO FINKIELSZTEIN
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Regulation Number
000.0000
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Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
02/27/2007
Decision Date
05/23/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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