FDA 510(k) Application Details - K190201

Device Classification Name Arthroscope

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510(K) Number K190201
Device Name Arthroscope
Applicant Providence Medical Technology, Inc.
3875 Hopyard Road, Suite 300
Pleasanton, CA 94588 US
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Contact Janie Mandrusov
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 02/04/2019
Decision Date 03/08/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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