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FDA 510(k) Application Details - K983016
Device Classification Name
Gauze/Sponge, Internal
More FDA Info for this Device
510(K) Number
K983016
Device Name
Gauze/Sponge, Internal
Applicant
VITALCARE GROUP, INC.
15800 N.W. 13TH AVE.
MIAMI, FL 33169 US
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Contact
GINGER TALLEY
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
EFQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/1998
Decision Date
02/12/1999
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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