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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K062038
Device Name X-STEN MILD TOOL KIT, MODEL MTK-0001
Applicant
X-Sten Corp.
2362 Qume Dr.
Suite D
San Jose,  CA  95131
Applicant Contact TIMOTHY M REEVES
Correspondent
X-Sten Corp.
2362 Qume Dr.
Suite D
San Jose,  CA  95131
Correspondent Contact TIMOTHY M REEVES
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/19/2006
Decision Date 12/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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