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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
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