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FDA 510(k) Application Details - K971178
Device Classification Name
Gauze/Sponge, Internal
More FDA Info for this Device
510(K) Number
K971178
Device Name
Gauze/Sponge, Internal
Applicant
TRANS AIRE
4135 NORTHGATE BLVD. SUITE 9
SACRAMENTO, CA 95834 US
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Contact
DUANE TRACY
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
EFQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/1997
Decision Date
06/27/1997
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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