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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K003347
Device Name ORTHOPILOT
Applicant
KINAMED, INC.
9229 CRANFORD DR.
POTOMAC,  MD  20854
Applicant Contact JOEL SLOMOFF
Correspondent
KINAMED, INC.
9229 CRANFORD DR.
POTOMAC,  MD  20854
Correspondent Contact JOEL SLOMOFF
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/25/2000
Decision Date 02/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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