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FDA 510(k) Application Details - K091398
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K091398
Device Name
Arthroscope
Applicant
ORTHOPEDIC SCIENCES, INC
3020 OLD RANCH PARKWAY
SUITE 325
SEAL BEACH, CA 90740 US
Other 510(k) Applications for this Company
Contact
JAMES K BRANNON
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
05/12/2009
Decision Date
08/26/2009
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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