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FDA 510(k)

NOVUS STANDARD AND PEDIATRIC VALVES

K-Number: K961859 · 1996-12-16

ApplicantIntegra Neurocare, LLC
Decision Date1996-12-16
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NOVUS STANDARD AND PEDIATRIC VALVES is the device name listed in this FDA 510(k) record. The listed applicant is Integra Neurocare, LLC. It received FDA 510(k) clearance on 1996-12-16 under 510(k) number K961859. 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 NOVUS STANDARD AND PEDIATRIC VALVES?

NOVUS STANDARD AND PEDIATRIC VALVES is a medical device that received FDA 510(k) clearance on 1996-12-16. The listed applicant is Integra Neurocare, LLC. The 510(k) number is K961859.

When did NOVUS STANDARD AND PEDIATRIC VALVES receive FDA 510(k) clearance?

NOVUS STANDARD AND PEDIATRIC VALVES received FDA 510(k) clearance on 1996-12-16, under 510(k) number K961859.

Who is the listed applicant for NOVUS STANDARD AND PEDIATRIC VALVES?

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

What is the FDA product code for NOVUS STANDARD AND PEDIATRIC VALVES?

The FDA product code for NOVUS STANDARD AND PEDIATRIC VALVES is JXG.

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Other records listing Integra Neurocare, LLC as applicant

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Related Devices (Code: JXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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