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FDA 510(k) Application Details - K101561
Device Classification Name
Instrument, Ultrasonic Surgical
More FDA Info for this Device
510(K) Number
K101561
Device Name
Instrument, Ultrasonic Surgical
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
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LFL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/2010
Decision Date
08/27/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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