DSG Connect Technology
FDA 510(k) clearance K201454 · decided 2021-02-10
Clearance details
- K-number
- K201454
- Device name
- DSG Connect Technology
- Applicant
- Spineguard S.A.
- Decision
- Substantially Equivalent
- Date received
- 2020-06-01
- Decision date
- 2021-02-10
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- PDQ
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Vincennes, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.