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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wheelchair, powered
510(k) Number K112815
Device Name QUANTUM BARIATRIC 451
Original Applicant
PRIDE MOBILITY PRODUCT CORPORRATION
182 susquehanna ave.
exeter,  PA  18643
Original Contact kimberly blake
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/27/2011
Decision Date 02/29/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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