FDA 510(k) Application Details - K971302

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K971302
Device Name Instrument, Ultrasonic Surgical
Applicant ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
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Contact LONNIE PACE
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 04/08/1997
Decision Date 07/07/1997
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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