MPU — Source, Chemiluminescent Light Class II

FDA Device Classification

FDA product code MPU covers "Source, Chemiluminescent Light", a Class II medical device regulated under 21 CFR 884.4530. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MPU
Device Class
Class II
Regulation Number
884.4530
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K012070trylonORALLITE COMPREHENSIVE EXAM TRAYNovember 27, 2001
K963391trylonSPECULITEDecember 12, 1997