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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 Road
Melville,  NY  11747
Applicant Contact Samir Ghevariya
Correspondent
Air Techniques Inc.
1295 Walt Whitman Road
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 Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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