FDA 510(k) Application Details - K180876

Device Classification Name Arthroscope

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510(K) Number K180876
Device Name Arthroscope
Applicant Providence Medical Technology, Inc.
3857 Hopyard Rd.
Suite 300
Pleasanton, CA 94588 US
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Contact Edward Liou
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 04/03/2018
Decision Date 05/18/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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