510(k) DEN170075
- Device
- ContainOR
- Applicant
- Advanced Surgical Concepts, Ltd.
- 510(k) number
- DEN170075
- Product code
- PZQ
- Decision
- Unknown (DENG)
- Decision date
- 2017-12-19
- Date received
- 2017-09-29
- Regulation
- 878.4825
- Classification name
- General Laparoscopic Power Morcellation Containment System
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- 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 A98 E339 A98 E339
Source Documents#
510(k) summary PDF not indicated by FDA