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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 K162442
Device Name ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
Applicant
Gri Medical & Electrical Technology Co., Ltd.
1805 Honggao Rd., Xiuzhou Industry Zone
Jiaxing,  CN 314031
Applicant Contact Martin D. Paugh
Correspondent
Sterilization Consulting Services, LLC
10051 Oak Leaf Way
Highlands Ranch,  CO  80129
Correspondent Contact Harry L. Shaffer
Regulation Number878.4040
Classification Product Code
FYA  
Date Received08/31/2016
Decision Date 12/12/2016
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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