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FDA 510(k)

KOWA SL-15

K-Number: K063640 · 2006-12-18

ApplicantKowa Co. , Ltd.
Decision Date2006-12-18
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOWA SL-15 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 2006-12-18 under 510(k) number K063640. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOWA SL-15?

KOWA SL-15 is a medical device that received FDA 510(k) clearance on 2006-12-18. The listed applicant is Kowa Co. , Ltd.. The 510(k) number is K063640.

When did KOWA SL-15 receive FDA 510(k) clearance?

KOWA SL-15 received FDA 510(k) clearance on 2006-12-18, under 510(k) number K063640.

Who is the listed applicant for KOWA SL-15?

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 KOWA SL-15?

The FDA product code for KOWA SL-15 is HJO.

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 AK083387MODIFICATION TO KOWA NONMYD ALPHA-DIII

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Related Devices (Code: HJO)

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.

K262637SLIT LAMP SL-D4 (Type: LED)Topcon CorporationK253834VISUREF 600Carl Zeiss Vision GmbHK231760HP-OCT (HP-OCT)Cylite Pty. , Ltd.K222372Kowa SL-19Kowa Company , Ltd.K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)K182306Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument Co., Ltd.

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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