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FDA 510(k)

MICROCAPILLARY INFUSION SYSTEM

K-Number: K831347 · 1983-06-02

ApplicantJ.S. Biomedicals, Inc.
Decision Date1983-06-02
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MICROCAPILLARY INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is J.S. Biomedicals, Inc.. It received FDA 510(k) clearance on 1983-06-02 under 510(k) number K831347. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROCAPILLARY INFUSION SYSTEM?

MICROCAPILLARY INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is J.S. Biomedicals, Inc.. The 510(k) number is K831347.

When did MICROCAPILLARY INFUSION SYSTEM receive FDA 510(k) clearance?

MICROCAPILLARY INFUSION SYSTEM received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831347.

Who is the listed applicant for MICROCAPILLARY INFUSION SYSTEM?

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

What is the FDA product code for MICROCAPILLARY INFUSION SYSTEM?

The FDA product code for MICROCAPILLARY INFUSION SYSTEM is FFX.

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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.

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