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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name extracorporeal shock wave device for treatment of diabetic foot ulcers
510(k) Number K202112
Device Name Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
Storz Medical AG
Lohstampfestrasse 8
Tagerwilen,  CH CH-8274
Applicant Contact Pavel Novak
Biomed Research, Inc.
3959 Van Dyke Road, Suite 245
Lutz,  FL  33558
Correspondent Contact Michael Dayton
Regulation Number878.4685
Classification Product Code
Date Received07/30/2020
Decision Date 02/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No