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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 K992310
Device Name TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.
Applicant
Rupiani Medical
98 Rue Alexandre Dumas
Vaulx En Velin,  FR 69120
Applicant Contact JEAN-MARIE MANGENOT
Correspondent
Rupiani Medical
98 Rue Alexandre Dumas
Vaulx En Velin,  FR 69120
Correspondent Contact JEAN-MARIE MANGENOT
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/09/1999
Decision Date 11/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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