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FDA 510(k)

THERMO FINER CORETEMP

K-Number: K760948 · 1976-12-09

ApplicantTerumo America, Inc.
Decision Date1976-12-09
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMO FINER CORETEMP 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 1976-12-09 under 510(k) number K760948. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO FINER CORETEMP?

THERMO FINER CORETEMP is a medical device that received FDA 510(k) clearance on 1976-12-09. The listed applicant is Terumo America, Inc.. The 510(k) number is K760948.

When did THERMO FINER CORETEMP receive FDA 510(k) clearance?

THERMO FINER CORETEMP received FDA 510(k) clearance on 1976-12-09, under 510(k) number K760948.

Who is the listed applicant for THERMO FINER CORETEMP?

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 THERMO FINER CORETEMP?

The FDA product code for THERMO FINER CORETEMP is FLL.

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Other records listing Terumo America, 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.

K811523PLASMA FLEXK802970TERUMO HOLLOW FIBER OXYGENATORK802122CLIRANS TH13 HOLLOW FIBER DIALYZERK802441CLIRANS TH10 HOLLOW FIBER DIALYZERK801193CLIRANS TE15 HOLLOW FIBER DIALYZERK801194CLIRANS TE07 HOLLOW FIBER DIALYZER

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Related Devices (Code: FLL)

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.

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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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