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510(k) K221637

Surgical Gown (Sterile); Surgical Gown (Non-sterile) by Allmed Medical (Hubei) Protective Products Co., Ltd. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2022
Date Received
June 6, 2022
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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