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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 K060043
Device Name KHAN KINETIC TREATMENT DEVICE (KKT-M1)
Applicant
Optima Health Solutions International, Inc.
Unit 303, 828 W. 8th Ave.
Vancouver, British Columbia,  CA V5Z 1E2
Applicant Contact BRAM RAMJIAWAN
Correspondent
Optima Health Solutions International, Inc.
Unit 303, 828 W. 8th Ave.
Vancouver, British Columbia,  CA V5Z 1E2
Correspondent Contact BRAM RAMJIAWAN
Classification Product Code
LXM  
Date Received01/06/2006
Decision Date 03/23/2006
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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