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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 K042444
Device Name LITESTREAM 500E
Applicant
Pride Mobility Products Corp.
182 Susquehanna Ave.
Exeter,  PA  18643
Applicant Contact THOMAS SCHAPPERT
Correspondent
Pride Mobility Products Corp.
182 Susquehanna Ave.
Exeter,  PA  18643
Correspondent Contact THOMAS SCHAPPERT
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/09/2004
Decision Date 10/21/2004
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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