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FDA 510(k) Application Details - K153548
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K153548
Device Name
Arthroscope
Applicant
VISIONSENSE LTD
20 HAMAGSHIMIM ST
PETACH TIKVA, HAMERKAZ 49348 IL
Other 510(k) Applications for this Company
Contact
ALEX CHANIN
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
12/11/2015
Decision Date
02/22/2016
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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