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FDA 510(k) Application Details - K982841
Device Classification Name
Instrument, Ultrasonic Surgical
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510(K) Number
K982841
Device Name
Instrument, Ultrasonic Surgical
Applicant
MISONIX, INC.
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LFL
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More FDA Info for this Product Code
Date Received
08/12/1998
Decision Date
09/04/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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