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510(k) K233294

Device
Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
Applicant
Itp Innovative Tomography Products GmbH
510(k) number
K233294
Product code
KNW
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-18
Date received
2023-09-29
Regulation
876.1075
Classification name
Instrument, Biopsy
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dominik Främke
Address
Universitätsstraße 136 Bochum DE 44799 44799

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KNW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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