FDA 510(k) Application Details - K171237

Device Classification Name Arthroscope

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510(K) Number K171237
Device Name Arthroscope
Applicant Medos International SARL
Chemin-Blanc 38
Le Locle Neuchatel 2400 CH
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Contact Tatyana Korsunsky
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 04/27/2017
Decision Date 01/18/2018
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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