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FDA 510(k) Application Details - K013056
Device Classification Name
Dressing, Wound, Drug
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510(K) Number
K013056
Device Name
Dressing, Wound, Drug
Applicant
SINCLAIR PHARMACEUTICALS, LTD.
1 ALDER BROOK
CHINLEY, HIGH PEAK SK23 6DN GB
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Contact
PRISCILLA COX
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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
09/11/2001
Decision Date
12/21/2001
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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