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FDA 510(k)

THE BIOPLATE SHUNT CONNECTOR

K-Number: K984583 · 1999-03-15

ApplicantBiomedics
Decision Date1999-03-15
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THE BIOPLATE SHUNT CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Biomedics. It received FDA 510(k) clearance on 1999-03-15 under 510(k) number K984583. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE BIOPLATE SHUNT CONNECTOR?

THE BIOPLATE SHUNT CONNECTOR is a medical device that received FDA 510(k) clearance on 1999-03-15. The listed applicant is Biomedics. The 510(k) number is K984583.

When did THE BIOPLATE SHUNT CONNECTOR receive FDA 510(k) clearance?

THE BIOPLATE SHUNT CONNECTOR received FDA 510(k) clearance on 1999-03-15, under 510(k) number K984583.

Who is the listed applicant for THE BIOPLATE SHUNT CONNECTOR?

The FDA 510(k) record lists Biomedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE BIOPLATE SHUNT CONNECTOR?

The FDA product code for THE BIOPLATE SHUNT CONNECTOR is JXG.

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Other records listing Biomedics as applicant

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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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