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FDA 510(k) Application Details - K093062
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K093062
Device Name
Arthroscope
Applicant
X-STEN CORP.
1193 SHERMAN ST.
ALAMEDA, CA 94501-1841 US
Other 510(k) Applications for this Company
Contact
CRAIG COOMBS
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
09/30/2009
Decision Date
02/04/2010
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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