510(k) DEN220082
- Device
- Breast Implant Removal Device (BIRD)
- Applicant
- Gaylord Solutions, LLC
- 510(k) number
- DEN220082
- Product code
- QVS
- Decision
- Unknown (DENG)
- Decision date
- 2023-04-20
- Date received
- 2022-11-21
- Regulation
- 878.4675
- Classification name
- Breast Implant Suction Retrieval Device
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Alex Cerveniak
- Address
- 1258 Old 27 N Gaylord MI US 49735 49735
FDA Registration Numbers#
- 1526012
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QVS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252438 | Explant Express | Applied Medical Technology, Inc. | 2026-02-03 |