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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K212046
Device Name Impertech Surgical Face Mask
Applicant
Impertech Industries , Ltd.
20 Derech Barkan St.
Barkan,  IL 4482000
Applicant Contact Mohamad Khweis
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Vaibhav Arvind Rajal
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/30/2021
Decision Date 11/18/2021
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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