FDA 510(k) Application Details - K961738

Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered

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510(K) Number K961738
Device Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Applicant SCIERAN TECHNOLOGIES, INC.
27071 CABOT RD., SUITE 127
LAGUNA HILLS, CA 92653 US
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Contact ROD ROSS
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Regulation Number 886.4150

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Classification Product Code HQE
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Date Received 05/03/1996
Decision Date 11/25/1996
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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