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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 K934297
Device Name DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR
Applicant
Durable Medical Equipment, Inc.
105 W. St.
Po Drawer 929
Pittsboro,  NC  27312
Applicant Contact TIM HUBBARD
Correspondent
Durable Medical Equipment, Inc.
105 W. St.
Po Drawer 929
Pittsboro,  NC  27312
Correspondent Contact TIM HUBBARD
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/02/1993
Decision Date 11/01/1993
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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