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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 K945533
Device Name MECHANICAL WHEELCHAIR - SUPERNOVA
Applicant
Colours 'N Motion
1591 S. Sinclair St.
Anaheim,  CA  92806
Applicant Contact JOHN G BOX
Correspondent
Colours 'N Motion
1591 S. Sinclair St.
Anaheim,  CA  92806
Correspondent Contact JOHN G BOX
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/14/1994
Decision Date 01/02/1995
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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