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FDA 510(k) Application Details - K141557
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K141557
Device Name
Arthroscope
Applicant
GALLINI MEDICAL DEVICES, SRL
1531 FELTON ROAD
SOUTH EUCLID, OH 44121 US
Other 510(k) Applications for this Company
Contact
ARTHUR S GODDARD
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/12/2014
Decision Date
12/08/2014
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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