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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
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