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FDA 510(k)

TERUFUSION DONOR SET

K-Number: K771207 · 1977-07-14

ApplicantTerumo America, Inc.
Decision Date1977-07-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TERUFUSION DONOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Terumo America, Inc.. It received FDA 510(k) clearance on 1977-07-14 under 510(k) number K771207. 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 TERUFUSION DONOR SET?

TERUFUSION DONOR SET is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Terumo America, Inc.. The 510(k) number is K771207.

When did TERUFUSION DONOR SET receive FDA 510(k) clearance?

TERUFUSION DONOR SET received FDA 510(k) clearance on 1977-07-14, under 510(k) number K771207.

Who is the listed applicant for TERUFUSION DONOR SET?

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

What is the FDA product code for TERUFUSION DONOR SET?

The FDA product code for TERUFUSION DONOR SET is FMI.

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Related Devices (Code: FMI)

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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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