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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 K203548
Device Name EndoArmor™ + Surgical Gown
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact Laura Kuroski
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact Laura Meehan
Regulation Number878.4040
Classification Product Code
FYA  
Date Received12/04/2020
Decision Date 02/21/2022
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
Predetermined Change
Control Plan Authorized		 No
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