510(k) K802291
K802291 is an FDA 510(k) premarket notification submitted by Strato-Ray Co. for the device "FLUORESCENT SUN LAMP FIXTURE". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code HJE (Lamp, Fluorescein, Ac-Powered), a Class II device regulated under 21 CFR 878.4580. Strato-Ray Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1980
- Date Received
- September 19, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Fluorescein, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type