FRQ — Tube, Levine Class II

FDA Device Classification

FDA product code FRQ covers "Tube, Levine", a Class II medical device regulated under 21 CFR 876.5980. Submissions are reviewed by the Gastroenterology, Urology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FRQ
Device Class
Class II
Regulation Number
876.5980
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K914887mallinckrodt medicalESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCTMay 8, 1992
K914530icn pharmaceuticalsICAN GT DRAINAGE BAGDecember 18, 1991
K802007pollak (intl.)PEDIWET=GUAZE IMPREGNATED WITH PETROLSeptember 26, 1980