510(k) K934808

UVISOL AND UVISOL II by National Biological Corp. — Product Code FTC

K934808 is an FDA 510(k) premarket notification submitted by National Biological Corp. for the device "UVISOL AND UVISOL II". The FDA issued a decision of Substantially Equivalent on December 16, 1993. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. National Biological Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1993
Date Received
October 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Ultraviolet, Dermatological
Device Class
Class II
Regulation Number
878.4630
Review Panel
SU
Submission Type