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FDA 510(k) Application Details - K983448
Device Classification Name
Tubing, Replacement, Phacofragmentation Unit
More FDA Info for this Device
510(K) Number
K983448
Device Name
Tubing, Replacement, Phacofragmentation Unit
Applicant
MED-LOGICS, INC.
30251 GOLDEN LANTERN
SUITE E-207
LAGUNA NIGUEL, CA 92677 US
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BETTY ROSS
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Regulation Number
886.4150
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Classification Product Code
MSR
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More FDA Info for this Product Code
Date Received
09/30/1998
Decision Date
12/18/1998
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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