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FDA 510(k) Application Details - K032983
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K032983
Device Name
Dressing, Wound, Drug
Applicant
SCIVOLUTION, INC.
962 ALLEGRO LANE
APOLLO BEACH, FL 33572 US
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Contact
ARTHUR WARD
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
09/24/2003
Decision Date
06/01/2004
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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