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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K193389
Device Name Vista Clear
Applicant
Inter-Med / Vista Dental Products
2200 South St. Ste. A
Racine,  WI  53404
Applicant Contact Alex Johnson
Correspondent
Inter-Med / Vista Dental Products
2200 South St. Ste. A
Racine,  WI  53404
Correspondent Contact Alex Johnson
Classification Product Code
MVL  
Date Received12/06/2019
Decision Date 03/04/2020
Decision Substantially Equivalent (SESE)
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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