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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
Applicant
Inter-Med, Inc.
2200 S. St.
Racine,  WI  53404
Applicant Contact Brett Arand
Correspondent
Inter-Med, Inc.
2200 S. St.
Racine,  WI  53404
Correspondent Contact Brett Arand
Regulation Number872.4200
Classification Product Code
NYL  
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
Predetermined Change
Control Plan Authorized		 No
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