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FDA 510(k) Application Details - K973749
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K973749
Device Name
Unit, Phacofragmentation
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
886.4670
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Classification Product Code
HQC
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More FDA Info for this Product Code
Date Received
10/01/1997
Decision Date
12/08/1997
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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