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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 K190220
Device Name Vista FS, Vista FS Liquid
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 Received02/05/2019
Decision Date 06/10/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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