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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 K203710
Device Name Storz Medical MAGNETOLITH Muscle Stimulator
Applicant
Storz Medical Ag
Lohstampfestrasse 8
Tagerwilen,  CH CH-8274
Applicant Contact Pavel Novak
Correspondent
Biomed Research, Inc.
3959 Van Dyke Rd., Suite 245
Lutz,  FL  33558
Correspondent Contact Michael Dayton
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
NGX  
Date Received12/21/2020
Decision Date 05/03/2021
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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