FDA 510(k) Application Details - K971173

Device Classification Name Device, Irrigation, Ocular Surgery

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510(K) Number K971173
Device Name Device, Irrigation, Ocular Surgery
Applicant MED-LOGICS, INC.
27071 CABOT ROAD, SUITE 127
LAGUNA HILLS, CA 92653 US
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Contact ROD ROSS
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Regulation Number 886.4360

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Classification Product Code KYG
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Date Received 03/31/1997
Decision Date 05/22/1997
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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