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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K101719
Device Name TACAMO MANUAL WHEELCHAIR
Applicant
Dalton Instrument Corp.
3788 Arapaho Rd.
Addiison,  TX  75001
Applicant Contact MEI LEIN
Correspondent
Dalton Instrument Corp.
3788 Arapaho Rd.
Addiison,  TX  75001
Correspondent Contact MEI LEIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received06/18/2010
Decision Date 08/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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