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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 K103212
Device Name ROUGHRIDER
Applicant
Whirlwind Wheelchair International
1600 Holloway Ave.
Sci 251
San Francisco,  CA  94132
Applicant Contact MARC KRIZACK
Correspondent
Whirlwind Wheelchair International
1600 Holloway Ave.
Sci 251
San Francisco,  CA  94132
Correspondent Contact MARC KRIZACK
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/01/2010
Decision Date 01/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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