510(k) K761094
K761094 is an FDA 510(k) premarket notification submitted by Dermatron Corp. for the device "UVA PHOTOTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 2, 1976. The device falls under product code KGL (Cabinet, Phototherapy (Puva)), a Class II device regulated under 21 CFR 878.4630. Dermatron Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1976
- Date Received
- November 23, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cabinet, Phototherapy (Puva)
- Device Class
- Class II
- Regulation Number
- 878.4630
- Review Panel
- SU
- Submission Type