FDA 510(k) Application Details - K200729

Device Classification Name Arthroscope

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510(K) Number K200729
Device Name Arthroscope
Applicant HydroCision, Inc.
267 Boston Rd, Suite 28
North Billerica, MA 01862 US
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Contact Mark J Lewis
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 03/20/2020
Decision Date 04/16/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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