ContainOR
FDA 510(k) clearance DEN170075 · decided 2017-12-19
Clearance details
- K-number
- DEN170075
- Device name
- ContainOR
- Applicant
- Advanced Surgical Concepts, Ltd.
- Decision
- Unknown
- Date received
- 2017-09-29
- Decision date
- 2017-12-19
- Days to decision
- 81 days
- Clearance type
- Direct
- Product code
- PZQ
- Device class
- 2
- Regulation number
- 878.4825
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bray, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.