510(k) K771486
K771486 is an FDA 510(k) premarket notification submitted by Technilab for the device "DUAL LAB-LITE LIGHT BOX". The FDA issued a decision of Substantially Equivalent on August 22, 1977. The device falls under product code DJS (U.V. Light, Tlc), a Class I device regulated under 21 CFR 862.2270.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 1977
- Date Received
- August 1, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- U.V. Light, Tlc
- Device Class
- Class I
- Regulation Number
- 862.2270
- Review Panel
- TX
- Submission Type