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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 K093062
Device Name VERTOS MEDICAL MILD DEVICE KIT
Applicant
X-STEN CORP.
1193 SHERMAN ST.
ALAMEDA,  CA  94501 -1841
Applicant Contact CRAIG COOMBS
Correspondent
X-STEN CORP.
1193 SHERMAN ST.
ALAMEDA,  CA  94501 -1841
Correspondent Contact CRAIG COOMBS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/30/2009
Decision Date 02/04/2010
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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