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510(k) K210131

ComfortGuard Surgical Isolation Gown by Gri-Alleset, Inc. — Product Code FYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2021
Date Received
January 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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