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

Dilator, Lachrymal

21 CFR 886.4350 / Ophthalmic
FDA source (opens on fda.gov)

HNW is the FDA product code for Dilator, Lachrymal, a class I device type, regulated under 21 CFR 886.4350. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HNW
Device name
Dilator, Lachrymal
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
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
0

Clearances, product code HNW

By decision year
3 clearances under product code HNW with a decision year between 1981 and 1986, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HNW by decision year
YearClearances
19811
19841
19861

Applicants with the most clearances

Product code HNW
Applicants holding the most 510(k) clearances under product code HNW
ApplicantClearances
Intermedics Intraocular, Inc.1
Koi, Inc.1
Premier Dental Products Co1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 133 companies shown, in name order