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510(k) K213068

Medline Smoke Evacuation Shroud by Medline Industries, Inc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2022
Date Received
September 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

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