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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 K093717
Device Name C-MOR VISUALIZATION DEVICE
Applicant
Axis Surgical Technologies, Inc.
325 E. Middlefield Rd.
Mountain View,  CA  94043
Applicant Contact JAMES FARNWORTH
Correspondent
Axis Surgical Technologies, Inc.
325 E. Middlefield Rd.
Mountain View,  CA  94043
Correspondent Contact JAMES FARNWORTH
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/02/2009
Decision Date 03/02/2010
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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