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FDA 510(k)

KOI LACREMAL HOOK & DILATOR

K-Number: K812097 · 1981-08-18

ApplicantKoi, Inc.
Decision Date1981-08-18
Product CodeHNW
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOI LACREMAL HOOK & DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Koi, Inc.. It received FDA 510(k) clearance on 1981-08-18 under 510(k) number K812097. The device is classified under product code HNW. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOI LACREMAL HOOK & DILATOR?

KOI LACREMAL HOOK & DILATOR is a medical device that received FDA 510(k) clearance on 1981-08-18. The listed applicant is Koi, Inc.. The 510(k) number is K812097.

When did KOI LACREMAL HOOK & DILATOR receive FDA 510(k) clearance?

KOI LACREMAL HOOK & DILATOR received FDA 510(k) clearance on 1981-08-18, under 510(k) number K812097.

Who is the listed applicant for KOI LACREMAL HOOK & DILATOR?

The FDA 510(k) record lists Koi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KOI LACREMAL HOOK & DILATOR?

The FDA product code for KOI LACREMAL HOOK & DILATOR is HNW.

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Other records listing Koi, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K843247KOI PACHYMETERK830366DIAMOND KNIFEK812764KOI BLUE FIELD ENTOPTOSCOPEK812450KOI DIAMOND KNIFEK812010KOI LACRIMAL INTUBATION SYSTEMK812011BLADE GAUGE

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Related Devices (Code: HNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K862070INTER-SHARPIntermedics Intraocular, Inc.K841002LACHRYMAL PROBES-VARIOUSPremier Dental Products Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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