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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 K222462
Device Name Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-autom
Applicant
ITP Innovative Tomography Products GmbH
Universitaetsstr. 136
Bochum,  DE 44799
Applicant Contact Dr. Heinz-Werner Henke
Correspondent
ITP Innovative Tomography Products GmbH
Universitaetsstr. 136
Bochum,  DE 44799
Correspondent Contact Dominik Fraemke
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/15/2022
Decision Date 01/20/2023
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
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