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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gown, surgical
510(k) Number K203237
Device Name Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
Applicant
Dukal Corporation
2 Fleetwood Court
Ronkonkoma,  NY  11779
Applicant Contact Megan Quevedo
Correspondent
Dukal Corporation
2 Fleetwood Court
Ronkonkoma,  NY  11779
Correspondent Contact Megan Quevedo
Regulation Number878.4040
Classification Product Code
FYA  
Date Received11/03/2020
Decision Date 03/18/2022
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
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