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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 K984565
Device Name TMC-EASY-302
Applicant
Tmc Magnetics & Machinery Corp.
55 Northern Blvd.
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Tmc Magnetics & Machinery Corp.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number890.3800
Classification Product Code
INI  
Date Received12/23/1998
Decision Date 02/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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