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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K220595
Device Name NeoNavia Biopsy System
Applicant
Neodynamics AB
Lejonvagen 14
Lidingo,  SE SE-181 32
Applicant Contact Anna Forsberg
Correspondent
Msquared Associates, Inc.
127 W. 30th St.,
9th Floor
New York,  NY  10001
Correspondent Contact LeAnn Latham
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
FCG  
Date Received03/01/2022
Decision Date 09/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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