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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name handpiece, air-powered, root canal irrigation
510(k) Number K211721
Device Name PS System
Inter-Med, INC.
2200 South Street
Racine,  WI  53404
Applicant Contact Brett Arand
Inter-Med, INC.
2200 South Street
Racine,  WI  53404
Correspondent Contact Brett Arand
Regulation Number872.4200
Classification Product Code
Date Received06/04/2021
Decision Date 12/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No