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FDA 510(k) Application Details - K955863
Device Classification Name
Dressing, Wound, Drug
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510(K) Number
K955863
Device Name
Dressing, Wound, Drug
Applicant
MOLNLYCKE/SCOTT HEALTH CARE
100 EAST 15TH ST.
SUITE 320
FORT WORTH, TX 76102 US
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Contact
RICHARD A HAMER
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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
12/27/1995
Decision Date
03/13/1996
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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