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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K202310
Device Name Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
Applicant
Wildcat Ppe, LLC
301 S. Trade Center Pkwy.
Conroe,  TX  77385
Applicant Contact Matthew McFarlane
Correspondent
Wildcat Ppe, LLC
301 S. Trade Center Pkwy.
Conroe,  TX  77385
Correspondent Contact Matthew McFarlane
Regulation Number878.4040
Classification Product Code
FYC  
Date Received08/14/2020
Decision Date 01/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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