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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K973929
Device Name NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM
Applicant
NEOTONUS, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact JAMES R VEALE
Correspondent
NEOTONUS, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact JAMES R VEALE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/15/1997
Decision Date 05/21/1998
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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