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FDA 510(k) Application Details - K070874
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K070874
Device Name
Arthroscope
Applicant
ARTHRO KINETICS INC.
8 FANEUIL HALL, 3RD FLOOR
BOSTON, MA 02109 US
Other 510(k) Applications for this Company
Contact
JAMES HOBBS
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
03/29/2007
Decision Date
11/02/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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