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FDA 510(k) Application Details - K972114
Device Classification Name
Instrument, Ultrasonic Surgical
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510(K) Number
K972114
Device Name
Instrument, Ultrasonic Surgical
Applicant
THE OLYMPUS OPTICAL CO.
55 NORTHERN BLVD.
GREAT NECK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
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Regulation Number
000.0000
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Classification Product Code
LFL
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More FDA Info for this Product Code
Date Received
06/05/1997
Decision Date
05/18/1998
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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