510(k) K760519
K760519 is an FDA 510(k) premarket notification submitted by Dermatron Corp. for the device "SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313". The FDA issued a decision of Substantially Equivalent on September 3, 1976. The device falls under product code IOB (Lamp, Infrared, Non Heating), a Class II device regulated under 21 CFR 890.5500. Dermatron Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 1976
- Date Received
- August 26, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Infrared, Non Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type