FDA 510(k)

HERAPIN LOCK FLUSH SOLUTION USE KIT

K-Number: K831765 · 1983-07-12

Decision Date1983-07-12

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HERAPIN LOCK FLUSH SOLUTION USE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Mpl Division. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K831765. 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 HERAPIN LOCK FLUSH SOLUTION USE KIT?

HERAPIN LOCK FLUSH SOLUTION USE KIT is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Smith & Nephew, Mpl Division. The 510(k) number is K831765.

When did HERAPIN LOCK FLUSH SOLUTION USE KIT receive FDA 510(k) clearance?

HERAPIN LOCK FLUSH SOLUTION USE KIT received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831765.

Who is the listed applicant for HERAPIN LOCK FLUSH SOLUTION USE KIT?

The FDA 510(k) record lists Smith & Nephew, Mpl Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERAPIN LOCK FLUSH SOLUTION USE KIT?

The FDA product code for HERAPIN LOCK FLUSH SOLUTION USE KIT is 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.