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510(k) K241272

Stryker Steri-Shield 8 Surgical Hoods and Togas by Stryker Instruments — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2024
Date Received
May 6, 2024
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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