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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 K982145
Device Name MEGA 3
Applicant
Mega Motion, Inc.
P.O. Box 3744
Scranton,  PA  18505
Applicant Contact PAUL GRONKA
Correspondent
Mega Motion, Inc.
P.O. Box 3744
Scranton,  PA  18505
Correspondent Contact PAUL GRONKA
Regulation Number890.3800
Classification Product Code
INI  
Date Received06/17/1998
Decision Date 04/14/1999
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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