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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 K190949
Device Name ScanX Barrier Envelopes
Applicant
Air Techniques, Inc.
1295 Walt Whitman Rd.
Melville,  NY  11747
Applicant Contact Samir Ghevariya
Correspondent
Air Techniques, Inc.
1295 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact Samir Ghevariya
Regulation Number878.4370
Classification Product Code
PEM  
Date Received04/11/2019
Decision Date 07/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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