FDA 510(k) Application Details - K980930

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K980930
Device Name Instrument, Ultrasonic Surgical
Applicant FIBRA SONICS, INC.
5312 N. ELSTON AVE.
CHICAGO, IL 60630 US
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Contact ROBERT BROHM
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 03/12/1998
Decision Date 09/22/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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