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510(k) K212717

Paneffort AAMI Level 3 Isolation Gown by Paneffort, LLC — Product Code FYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2022
Date Received
August 27, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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