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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 K850178
Device Name DALTON FOLDING WHEELCHAIRS
Applicant
Dalton Instrument Corp.
900 Frances Way 214
Richardson,  TX  75081
Applicant Contact MINJI LEIN
Correspondent
Dalton Instrument Corp.
900 Frances Way 214
Richardson,  TX  75081
Correspondent Contact MINJI LEIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/17/1985
Decision Date 04/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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