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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 K945936
Device Name JAZZY
Applicant
Pride Health Care, Inc.
259 W. 6th St.
West Wyoming,  PA  18644
Applicant Contact GEORGE AMADEI
Correspondent
Pride Health Care, Inc.
259 W. 6th St.
West Wyoming,  PA  18644
Correspondent Contact GEORGE AMADEI
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/05/1994
Decision Date 05/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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