FDA 510(k) Application Details - K100597

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K100597
Device Name Instrument, Ultrasonic Surgical
Applicant ETHICON ENDO-SURGERY, LLC
4545 CREEK RD.
CINCINNATI, OH 45242 US
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Contact MARCIA ARENTZ
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 03/02/2010
Decision Date 04/07/2010
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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