FDA 510(k) Application Details - K964601

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K964601
Device Name Instrument, Ultrasonic Surgical
Applicant VALLEYLAB, INC.
5920 LONGBOW DR.
BOULDER, CO 80301 US
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Contact PEGGY WALLINE
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 11/18/1996
Decision Date 01/16/1997
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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