510(k) DEN230084
- Device
- Dexter L6 System
- Applicant
- Distalmotion SA
- 510(k) number
- DEN230084
- Product code
- SDD
- Decision
- Unknown (DENG)
- Decision date
- 2024-10-25
- Date received
- 2023-12-15
- Regulation
- 878.4965
- Classification name
- Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Larry Carrier
- Address
- Rte. De La Corniche 3b Epalinges CH 1066 1066
FDA Registration Numbers#
- 3033118964
- 3008771447
- 3009611746
- 3006946276
Source Documents#
510(k) summary PDF not indicated by FDA