510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LBLClass II

Tube, Tympanostomy, Porous Polyethylene

21 CFR 874.3880 / Ear, Nose, Throat
FDA source (opens on fda.gov)

LBL is the FDA product code for Tube, Tympanostomy, Porous Polyethylene, a class II device type, regulated under 21 CFR 874.3880. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LBL
Device name
Tube, Tympanostomy, Porous Polyethylene
Regulation
21 CFR 874.3880
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code LBL

By decision year
1 clearance under product code LBL with a decision year between 1990 and 1990, 1990 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LBL by decision year
YearClearances
19901

Applicants with the most clearances

Product code LBL
Applicants holding the most 510(k) clearances under product code LBL
ApplicantClearances
J.S. Medical Assoc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LBL.