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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 K954370
Device Name WHEEL LEMASTER
Applicant
Heliarc Specialists, Inc.
2606 NW Vaughn
Portland,  OR  97210
Applicant Contact SUSAN R LEMASTER
Correspondent
Heliarc Specialists, Inc.
2606 NW Vaughn
Portland,  OR  97210
Correspondent Contact SUSAN R LEMASTER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/18/1995
Decision Date 11/29/1995
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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