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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 K954344
Device Name RUSSON INDUSTRIES FURNITURE QUALITY WHEELCHAIR
Applicant
Russon Industries
108 Taylors Mill Rd.
Downington,  PA  19335
Applicant Contact GARY R SUBERS
Correspondent
Russon Industries
108 Taylors Mill Rd.
Downington,  PA  19335
Correspondent Contact GARY R SUBERS
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/18/1995
Decision Date 10/13/1995
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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