The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Liver Access And Biopsy Sets.
Device ID | K171853 |
510k Number | K171853 |
Device Name: | Liver Access And Biopsy Sets |
Classification | Introducer, Catheter |
Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
Contact | David Lehr |
Correspondent | David Lehr Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-21 |
Decision Date | 2017-08-24 |
Summary: | summary |