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510(k) K212633

Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue by String King Lacrosse, LLC — Product Code FYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2021
Date Received
August 19, 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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