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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Goniometer, Ac-Powered
510(k) Number K962377
Device Name 3D-SPINE
Applicant
SKILL TECHNOLOGIES, INC.
1202 EAST MARYLAND AVE.,
SUITE 1G
PHOENIX,  AZ  85014
Correspondent
SKILL TECHNOLOGIES, INC.
1202 EAST MARYLAND AVE.,
SUITE 1G
PHOENIX,  AZ  85014
Regulation Number888.1500
Classification Product Code
KQX  
Date Received06/20/1996
Decision Date 09/03/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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