FDA 510(k)

DIRECT ANTIBIOTIC INFUSION KIT

K-Number: K113043 · 2011-12-20

Decision Date2011-12-20

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DIRECT ANTIBIOTIC INFUSION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Summit Medical Products, Inc.. It received FDA 510(k) clearance on 2011-12-20 under 510(k) number K113043. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECT ANTIBIOTIC INFUSION KIT?

DIRECT ANTIBIOTIC INFUSION KIT is a medical device that received FDA 510(k) clearance on 2011-12-20. The listed applicant is Summit Medical Products, Inc.. The 510(k) number is K113043.

When did DIRECT ANTIBIOTIC INFUSION KIT receive FDA 510(k) clearance?

DIRECT ANTIBIOTIC INFUSION KIT received FDA 510(k) clearance on 2011-12-20, under 510(k) number K113043.

Who is the listed applicant for DIRECT ANTIBIOTIC INFUSION KIT?

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

What is the FDA product code for DIRECT ANTIBIOTIC INFUSION KIT?

The FDA product code for DIRECT ANTIBIOTIC INFUSION KIT is LJS.

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Related Devices (Code: LJS)

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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.