FDA 510(k)

WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER

K-Number: K935505 · 1994-02-03

ApplicantKawasumi Laboratories Co., Ltd.

Decision Date1994-02-03

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories Co., Ltd.. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K935505. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER?

WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Kawasumi Laboratories Co., Ltd.. The 510(k) number is K935505.

When did WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER receive FDA 510(k) clearance?

WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER received FDA 510(k) clearance on 1994-02-03, under 510(k) number K935505.

Who is the listed applicant for WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER?

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

What is the FDA product code for WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER?

The FDA product code for WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER is FMI.

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Other records listing Kawasumi Laboratories Co., Ltd. as applicant

K994323KAWASUMI LABORATORIES PHILEBOTOMY SET K974829NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)K964117NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE K935514VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER K935506MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION K930012KAWASUMI LABORATORIES K-CUFF

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Official Source

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