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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 K926499
Device Name SHUTTLE SC-140
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 Received12/29/1992
Decision Date 03/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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