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

Kit, Earmold, Impression

21 CFR 874.3300 / Ear, Nose, Throat
FDA source (opens on fda.gov)

LDG is the FDA product code for Kit, Earmold, Impression, a class I device type, regulated under 21 CFR 874.3300. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LDG
Device name
Kit, Earmold, Impression
Regulation
21 CFR 874.3300
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code LDG

By decision year
2 clearances under product code LDG with a decision year between 1980 and 1983, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LDG by decision year
YearClearances
19801
19831

Applicants with the most clearances

Product code LDG
Applicants holding the most 510(k) clearances under product code LDG
ApplicantClearances
Coe Laboratories, Inc.1
Santa Barbara Medco, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code