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FDA 510(k)

MODIFICATION TO KOWA NONMYD ALPHA-DIII

K-Number: K083387 · 2009-01-16

ApplicantKowa Co. , Ltd.
Decision Date2009-01-16
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO KOWA NONMYD ALPHA-DIII is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Co. , Ltd.. It received FDA 510(k) clearance on 2009-01-16 under 510(k) number K083387. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO KOWA NONMYD ALPHA-DIII?

MODIFICATION TO KOWA NONMYD ALPHA-DIII is a medical device that received FDA 510(k) clearance on 2009-01-16. The listed applicant is Kowa Co. , Ltd.. The 510(k) number is K083387.

When did MODIFICATION TO KOWA NONMYD ALPHA-DIII receive FDA 510(k) clearance?

MODIFICATION TO KOWA NONMYD ALPHA-DIII received FDA 510(k) clearance on 2009-01-16, under 510(k) number K083387.

Who is the listed applicant for MODIFICATION TO KOWA NONMYD ALPHA-DIII?

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

What is the FDA product code for MODIFICATION TO KOWA NONMYD ALPHA-DIII?

The FDA product code for MODIFICATION TO KOWA NONMYD ALPHA-DIII is HKI.

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Other records listing Kowa Co. , Ltd. 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.

K112330KOWA VX-20K101628KOWA NONMYD WXK091098KOWAGENESIS-DFK091039KOWA, FM-600, MODEL LSS50K091683KOWA VX-10 AK082767KOWA NONMYD ALPHA-DIII

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Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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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