Exofin Precision Pen
FDA 510(k) clearance K212246 · decided 2021-09-09
Clearance details
- K-number
- K212246
- Device name
- Exofin Precision Pen
- Applicant
- Chemence Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-07-19
- Decision date
- 2021-09-09
- Days to decision
- 52 days
- Clearance type
- Special
- Product code
- MPN
- Device class
- 2
- Regulation number
- 878.4010
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.