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510(k) K242844

Medline Level 4 Surgical Gown with Breathable Sleeves by Medline Industries, LP — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2025
Date Received
September 20, 2024
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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