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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K243522
Device Name ViVi® Toga Premium
Applicant
Thi Total Healthcare Innovation GmbH
Gewerbestrasse 4
Feistritz Im Rosental,  AT 9181
Applicant Contact Karl Hintermann
Correspondent
Albert Rego PHD, Inc (D.B.A Rego Associates)
25401 Cabot Rd.
# 122
Laguna Hills,  CA  92653
Correspondent Contact Albert Rego
Regulation Number878.4040
Classification Product Code
FYA  
Date Received11/14/2024
Decision Date 05/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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