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510(k) K260725

BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) by Hindernis DE Mexico, S.A.P.I. DE C.V. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2026
Date Received
March 5, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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