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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K193602
Device Name LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
Applicant
Lv Liberty Vision Corporation
300 W. Rd., Unit 2
Portsmouth,  NH  03874
Applicant Contact Paul T. Finger
Correspondent
Lv Liberty Vision Corporation
300 W. Rd., Unit 2
Portsmouth,  NH  03874
Correspondent Contact Paul T. Finger
Regulation Number892.5730
Classification Product Code
KXK  
Date Received12/23/2019
Decision Date 05/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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