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FDA 510(k) Application Details - K073610
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K073610
Device Name
Dressing, Wound, Drug
Applicant
SWISS AMERICAN PRODUCTS, INC.
2055 LUNA RD., STE. 126
CARROLLTON, TX 75006 US
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Contact
ERIC LUO
Other 510(k) Applications for this Contact
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
12/21/2007
Decision Date
04/23/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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