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510(k) K211765

Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown by Cardinal Health, LLC — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2021
Date Received
June 8, 2021
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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