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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 K874317
Device Name POIRIER KID-ROLLER MANUAL WHEELCHAIR
Applicant
Roseburg SA
Suite 120 Canal Sq.
1054 31st St. NW
Washington,  DC  20007
Applicant Contact DARIENNE MOYER
Correspondent
Roseburg SA
Suite 120 Canal Sq.
1054 31st St. NW
Washington,  DC  20007
Correspondent Contact DARIENNE MOYER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received10/21/1987
Decision Date 11/17/1987
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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