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510(k) K202310

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back by Wildcat Ppe, LLC — Product Code FYC

K202310 is an FDA 510(k) premarket notification submitted by Wildcat Ppe, LLC for the device "Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back". The FDA issued a decision of Substantially Equivalent on Jan 29, 2021. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 29, 2021
Date Received
Aug 14, 2020
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
510(k)

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FDA data resources