FDA 510(k) Application Details - K201113

Device Classification Name Arthroscope

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510(K) Number K201113
Device Name Arthroscope
Applicant Advanced Medical Systems Group SRL
Via Europa 12
San Pietro Viminario 35020 IT
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Contact Francesco Sgarbi
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 04/27/2020
Decision Date 12/21/2020
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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