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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 K930952
Device Name PRIDE LEGEND SC-340
Applicant
Pride Health Care, Inc.
259 W. 6th St.
West Wyoming,  PA  18644
Applicant Contact THOMAS KRETCHIK
Correspondent
Pride Health Care, Inc.
259 W. 6th St.
West Wyoming,  PA  18644
Correspondent Contact THOMAS KRETCHIK
Regulation Number890.3800
Classification Product Code
INI  
Date Received02/23/1993
Decision Date 03/28/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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
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