FDA 510(k) Application Details - K241700

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K241700
Device Name Instrument, Ultrasonic Surgical
Applicant Trice Medical, Inc.
40 General Warren Blvd
Suite 100
Malvern, PA 19355 US
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Contact David Vancelette
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 06/13/2024
Decision Date 11/18/2024
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

FDA Source Information for K241700


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