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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 K885330
Device Name WHEELCHAIR, MECHANICAL
Applicant
Kaye Products, Inc.
1010 E. Pettigrew St.
Durham,  NC  27701
Applicant Contact EDWARD S HOWLE
Correspondent
Kaye Products, Inc.
1010 E. Pettigrew St.
Durham,  NC  27701
Correspondent Contact EDWARD S HOWLE
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/28/1988
Decision Date 02/03/1989
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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