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FDA 510(k) Application Details - K201113
Device Classification Name
Arthroscope
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
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More FDA Info for this Product Code
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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