510(k) DEN150028
- Device
- PneumoLiner
- Applicant
- Advanced Surgical Concepts, Ltd.
- 510(k) number
- DEN150028
- Product code
- PMU
- Decision
- Unknown (DENG)
- Decision date
- 2016-04-07
- Date received
- 2015-06-19
- Regulation
- 884.4050
- Classification name
- Containment System, Laparoscopic Power Morcellation, With Instrument Port
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- EDWARD HYLAND
- Address
- Unit 4 Sunnybank Center, Upper Dargle Rd. Bray IE IRL IRL
FDA Registration Numbers#
- 9610773
- 3013247477
- 3025598220
- 1220351
- 3005049530
- 2219920
- 3011050570
- 3023620966
Source Documents#
510(k) summary PDF not indicated by FDA