510(k) K770720
- Device
- TUBING PACK, EXTRACORPOREAL, H-3000
- Applicant
- William Harvey Life Products Corp.
- 510(k) number
- K770720
- Product code
- BYS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-04
- Date received
- 1977-04-18
- Regulation
- 870.4100
- Classification name
- Oxygenator, Long Term Support Greater Than 6 Hours
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3012172416
- 3030191221
- 9617601
- 3002845651
- 3011468686
- 9611665
- 2029275
Source Documents#
510(k) summary PDF not indicated by FDA