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RABClass II

Sunlamp Products (Pre-Standard)

21 CFR 878.4635 / General, Plastic Surgery
FDA source (opens on fda.gov)

RAB is the FDA product code for Sunlamp Products (Pre-Standard), a class II device type, regulated under 21 CFR 878.4635. FDA's definition for this code reads: "A sunlamp product assembled or manufactured before november 9, 1979. These are Class II medical devices as of 2014". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
RAB
Device name
Sunlamp Products (Pre-Standard)
FDA definition
A sunlamp product assembled or manufactured before november 9, 1979. These are Class II medical devices as of 2014.
Regulation
21 CFR 878.4635
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code