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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 K042612
Device Name JAZZY 600
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 Number890.3860
Classification Product Code
ITI  
Date Received09/24/2004
Decision Date 10/06/2004
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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