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FDA 510(k) Application Details - K080803
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K080803
Device Name
Unit, Phacofragmentation
Applicant
AMERICAN OPTISURGICAL, INC.
25501 ARCTIC OCEAN
LAKE FOREST, CA 92630 US
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Contact
DAVID SALZBERG
Other 510(k) Applications for this Contact
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
03/21/2008
Decision Date
09/22/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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