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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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ROD ROSS
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Regulation Number
886.4150
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Classification Product Code
HQE
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More FDA Info for this Product Code
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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