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

Gag, Mouth

21 CFR 874.4420 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KBN is the FDA product code for Gag, Mouth, a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KBN
Device name
Gag, Mouth
Regulation
21 CFR 874.4420
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
3
Ingested recalls
1

Clearances, product code KBN

By decision year
3 clearances under product code KBN with a decision year between 1978 and 1984, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KBN by decision year
YearClearances
19781
19821
19841

Applicants with the most clearances

Product code KBN
Applicants holding the most 510(k) clearances under product code KBN
ApplicantClearances
Imm Enterprises, Ltd.1
Kelleher Corp.1
Nestor Engineering Associates, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 203 companies shown, in name order