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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 K260725
Device Name BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
Applicant
Hindernis DE Mexico, S.A.P.I. DE C.V.
Carr. Naucalpan Ixlahuaca # 58, Col. Barrio De La Rosa
Naucalpan De Juarez,  MX 53216
Applicant Contact Eduardo Gras
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Charles Shen
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/05/2026
Decision Date 05/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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