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FDA 510(k) Application Details - K020318
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K020318
Device Name
Dressing, Wound, Drug
Applicant
SCIVOLUTIONS, INC
962 ALLEGRO LN.
APOLLO BEACH, FL 33572 US
Other 510(k) Applications for this Company
Contact
ART WARD
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/30/2002
Decision Date
02/03/2003
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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