510(k) BK180287
- Device
- Fibrin Sealant Preparation Device
- Applicant
- ETHICON Inc.
- 510(k) number
- BK180287
- Product code
- MZM
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2019-04-10
- Date received
- 2018-11-19
- Regulation
- 880.5860
- Classification name
- Fibrin Sealant Preparation Device
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No