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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K943535
Device Name MODEL ME 300 MUSCLE TESTER
Applicant
Regulatory Strategies, Inc.
1660 Riverton Point
Eagan,  MN  55122
Applicant Contact GREGORY J MATHISON
Correspondent
Regulatory Strategies, Inc.
1660 Riverton Point
Eagan,  MN  55122
Correspondent Contact GREGORY J MATHISON
Regulation Number882.5050
Classification Product Code
HCC  
Date Received07/21/1994
Decision Date 06/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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