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FDA 510(k) Application Details - K113362
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K113362
Device Name
Arthroscope
Applicant
SPINE VIEW, INC.
48810 Kato Rd. Suite 100E
Fremont, CA 94538 US
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Contact
SEVRINA CIUCCI
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
11/15/2011
Decision Date
02/10/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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