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510(k) K210414

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown by Medtecs (Taiwan) Corp. — Product Code FYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2022
Date Received
February 11, 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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