510(k) DEN080009
- Device
- AIRPURGE
- Applicant
- Anesthesia Safety Products, LLC
- 510(k) number
- DEN080009
- Product code
- OKL
- Decision
- Unknown (DENG)
- Decision date
- 2014-03-04
- Date received
- 2008-10-29
- Regulation
- 880.5445
- Classification name
- Intravascular Administration Set, Automated Air Removal System
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- IHSAN A HADDAD
- Address
- 155-M New Boston St. Suite 127 Woburn MA US 01801 01801
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OKL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171954 | ClearLine IV | Clearline MD | 2018-01-25 |