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FDA 510(k) Application Details - K093320
Device Classification Name
Dressing, Wound, Drug
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510(K) Number
K093320
Device Name
Dressing, Wound, Drug
Applicant
COLLEGIUM PHARMACEUTICAL INCORPORATED
400 HIGHLAND CORPORATE DRIVE
CUMBERLAND, RI 02864 US
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Contact
MARK W TRUMBORE
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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
10/23/2009
Decision Date
06/18/2010
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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