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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, cryosurgical, accessories
510(k) Number K190747
Device Name Claritag
DGI Technologies
500 River Ave
Lakewood,  NJ  08701
Applicant Contact Jeremy Josephson
Health Policy Associates
690 Canton Street, Suite 302
Westwood,  MA  02090
Correspondent Contact Russ Olsen
Regulation Number878.4350
Classification Product Code
Date Received03/22/2019
Decision Date 10/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No