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FDA 510(k) Application Details - K010353
Device Classification Name
Device, Irrigation, Ocular Surgery
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510(K) Number
K010353
Device Name
Device, Irrigation, Ocular Surgery
Applicant
MED-LOGICS, INC.
2788 LAPAZ RD. #G-316
LAGUNA NIGUEL,, CA 92677 US
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Contact
GARY MOCNIK
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Regulation Number
886.4360
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Classification Product Code
KYG
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More FDA Info for this Product Code
Date Received
02/06/2001
Decision Date
04/27/2001
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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