BIRTCHER UV LAMP
FDA 510(k) clearance K973865 · decided 1999-02-26
Clearance details
- K-number
- K973865
- Device name
- BIRTCHER UV LAMP
- Applicant
- Medfaxx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-06
- Decision date
- 1999-02-26
- Days to decision
- 508 days
- Clearance type
- Traditional
- Product code
- MXG
- Device class
- 2
- Regulation number
- 878.4630
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Raleigh, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.