510(k) K973865
K973865 is an FDA 510(k) premarket notification submitted by Medfaxx, Inc. for the device "BIRTCHER UV LAMP". The FDA issued a decision of Substantially Equivalent on February 26, 1999. The device falls under product code MXG (Lamp, Uvc, (For Treating Skin And Wounds)), a Class II device regulated under 21 CFR 878.4630.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1999
- Date Received
- October 6, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Uvc, (For Treating Skin And Wounds)
- Device Class
- Class II
- Regulation Number
- 878.4630
- Review Panel
- SU
- Submission Type