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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name vehicle, motorized 3-wheeled
510(k) Number K072165
Device Name VICTORY THREE WHEEL SCOOTER, MODEL: SC610
Applicant
PRIDE MOBILITY PRODUCTS CORP.
182 SUSQUEHANNA AVE.
EXETER,  PA  18643
Applicant Contact THOMAS J SCHAPPERT
Correspondent
PRIDE MOBILITY PRODUCTS CORP.
182 SUSQUEHANNA AVE.
EXETER,  PA  18643
Correspondent Contact THOMAS J SCHAPPERT
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/06/2007
Decision Date 08/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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