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FDA 510(k) Application Details - K974316
Device Classification Name
Gauze/Sponge, Internal
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510(K) Number
K974316
Device Name
Gauze/Sponge, Internal
Applicant
HYDROFERA, LLC.
322 MAIN ST., SUITE 1101
WILLIMANTIC, CT 06226 US
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Contact
HEATHER S BOND
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Regulation Number
000.0000
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Classification Product Code
EFQ
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More FDA Info for this Product Code
Date Received
11/17/1997
Decision Date
02/13/1998
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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