FDA 510(k)

L.O.N. DISPOSABLE CORONARY MANIFOLD

K-Number: K812408 · 1981-12-02

Decision Date1981-12-02

Product CodeDTL

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

L.O.N. DISPOSABLE CORONARY MANIFOLD is the device name listed in this FDA 510(k) record. The listed applicant is L.O.N. Research, Inc.. It received FDA 510(k) clearance on 1981-12-02 under 510(k) number K812408. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L.O.N. DISPOSABLE CORONARY MANIFOLD?

L.O.N. DISPOSABLE CORONARY MANIFOLD is a medical device that received FDA 510(k) clearance on 1981-12-02. The listed applicant is L.O.N. Research, Inc.. The 510(k) number is K812408.

When did L.O.N. DISPOSABLE CORONARY MANIFOLD receive FDA 510(k) clearance?

L.O.N. DISPOSABLE CORONARY MANIFOLD received FDA 510(k) clearance on 1981-12-02, under 510(k) number K812408.

Who is the listed applicant for L.O.N. DISPOSABLE CORONARY MANIFOLD?

The FDA 510(k) record lists L.O.N. Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for L.O.N. DISPOSABLE CORONARY MANIFOLD?

The FDA product code for L.O.N. DISPOSABLE CORONARY MANIFOLD is DTL.

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Other records listing L.O.N. Research, Inc. as applicant

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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.