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FDA 510(k) Application Details - K122662
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K122662
Device Name
Arthroscope
Applicant
VERTIFLEX, INC.
1351 Calle Avanzado
San Clemente, CA 92673 US
Other 510(k) Applications for this Company
Contact
STEVE REITZLER
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
08/31/2012
Decision Date
11/13/2012
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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