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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dental barriers and sleeves
510(k) Number K211026
Device Name Minitube Dentasleeve Protective Barrier Sleeves
Minitube AB
Byvägen 44
Trångsviken,  SE 83596
Applicant Contact Bengt Myhrman
MDI Consultants Inc.
55 Northen Blvd. Suite 200
Great Neck,  NY  11021
Correspondent Contact Vaibhav Arvind Rajal
Regulation Number878.4370
Classification Product Code
Date Received04/06/2021
Decision Date 08/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No