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FDA 510(k) Application Details - K974313
Device Classification Name
Sponge, Ophthalmic
More FDA Info for this Device
510(K) Number
K974313
Device Name
Sponge, Ophthalmic
Applicant
HYDROFERA, LLC.
322 MAIN ST., SUITE 1101
WILLIMANTIC, CT 06226 US
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Contact
HEATHER S BOND
Other 510(k) Applications for this Contact
Regulation Number
886.4790
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Classification Product Code
HOZ
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More FDA Info for this Product Code
Date Received
11/17/1997
Decision Date
03/02/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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