KOI LACREMAL HOOK & DILATOR— 510(k) K812097

Substantially Equivalent

Koi, Inc.

FDA 510(k) clearance K812097 for KOI LACREMAL HOOK & DILATOR, Substantially Equivalent on 1981-08-18. Applicant: Koi, Inc.. Device class: 1.

Clearance details

Applicant: Koi, Inc.
Product code: Code HNW
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1981-07-24
Decision date: 1981-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HNW

K862070 — INTER-SHARP1986-06-17
K841002 — LACHRYMAL PROBES-VARIOUS1984-05-09

More clearances from Koi, Inc.

K843247 — KOI PACHYMETER1986-04-30
K830366 — DIAMOND KNIFE1983-03-09
K812764 — KOI BLUE FIELD ENTOPTOSCOPE1981-12-02
K812450 — KOI DIAMOND KNIFE1981-09-21
K812010 — KOI LACRIMAL INTUBATION SYSTEM1981-07-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.