RAB

Sunlamp Products (Pre-Standard)

Product code
RAB
Device name
Sunlamp Products (Pre-Standard)
Device class
Class 2
21 CFR
21 CFR 878.4635
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
GMP exempt
Flag
Third-party review eligible

FDA classification definition

A sunlamp product assembled or manufactured before november 9, 1979. These are Class II medical devices as of 2014.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: RAB
Classification and pathway per current FDA publications. Data from openFDA (CC0).