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FDA 510(k) Application Details - K111168
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K111168
Device Name
Dressing, Wound, Drug
Applicant
PRECISION DERMATOLOGY INCORPORATED
900 HIGHLAND CORPORATE DRIVE
CUMBERLAND, RI 02864 US
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Contact
RONALD M GURGE, PH.D
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Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
04/25/2011
Decision Date
12/13/2011
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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