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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 K896025
Device Name THE SHUTTLE (TM) THREE WHEEL SCOOTER
Applicant
Pride Health Care, Inc.
71 S. Main St.
Pittston,  PA  18640
Applicant Contact THOMAS KRETCHIK
Correspondent
Pride Health Care, Inc.
71 S. Main St.
Pittston,  PA  18640
Correspondent Contact THOMAS KRETCHIK
Regulation Number890.3800
Classification Product Code
INI  
Date Received10/17/1989
Decision Date 11/22/1989
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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