Fibrin Sealant Preparation Device
Fibrin Sealant Preparation Device
ETHICON Inc.
The following data is part of a premarket notification filed by Ethicon Inc. with the FDA for Fibrin Sealant Preparation Device.
Pre-market Notification Details
Device ID | BK190324 |
510k Number | BK190324 |
Device Name: | Fibrin Sealant Preparation Device |
Classification | Fibrin Sealant Preparation Device |
Applicant | ETHICON Inc. route 22 West p.o. Box 151 Somerville, NJ 08876 US |
Product Code | MZM |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-28 |
Decision Date | 2019-06-05 |
NIH GUDID Devices
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.