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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manipulator, Plunger-Like Joint
510(k) Number K130666
Device Name KHAN KINETIC TREATMENT (KKT-M2)
Applicant
Optima Health Solutions International Corporation
303 - 828 W 8th Ave.
Vancouver,  CA V5Z 1E2
Applicant Contact FARHAD GHANI
Correspondent
Optima Health Solutions International Corporation
303 - 828 W 8th Ave.
Vancouver,  CA V5Z 1E2
Correspondent Contact FARHAD GHANI
Classification Product Code
LXM  
Date Received03/12/2013
Decision Date 01/23/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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