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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 K944122
Device Name DAB WELDLESS WHEELCHAIR
Applicant
Da Intl. , Ltd.
27940 Winding Way
Malibu,  CA  90265
Applicant Contact J. A KANEHANN
Correspondent
Da Intl. , Ltd.
27940 Winding Way
Malibu,  CA  90265
Correspondent Contact J. A KANEHANN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received08/23/1994
Decision Date 09/13/1994
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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