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FDA 510(k) Application Details - K983450
Device Classification Name
Gauze/Sponge, Internal
More FDA Info for this Device
510(K) Number
K983450
Device Name
Gauze/Sponge, Internal
Applicant
T.C. DENTAL PRODUCTS, INC.
20957 CURRIER RD., #E
WALNUT, CA 91789 US
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Contact
JEN WANG
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
09/30/1998
Decision Date
11/12/1998
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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