510(k) K802291

FLUORESCENT SUN LAMP FIXTURE by Strato-Ray Co. — Product Code HJE

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