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FDA 510(k)

VOLUMATIC

K-Number: K844169 · 1984-11-09

ApplicantGlaxo, Inc.
Decision Date1984-11-09
Product CodeKCD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VOLUMATIC is the device name listed in this FDA 510(k) record. The listed applicant is Glaxo, Inc.. It received FDA 510(k) clearance on 1984-11-09 under 510(k) number K844169. The device is classified under product code KCD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLUMATIC?

VOLUMATIC is a medical device that received FDA 510(k) clearance on 1984-11-09. The listed applicant is Glaxo, Inc.. The 510(k) number is K844169.

When did VOLUMATIC receive FDA 510(k) clearance?

VOLUMATIC received FDA 510(k) clearance on 1984-11-09, under 510(k) number K844169.

Who is the listed applicant for VOLUMATIC?

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

What is the FDA product code for VOLUMATIC?

The FDA product code for VOLUMATIC is KCD.

Related Clinical Trials

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Other records listing Glaxo, Inc. as applicant

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.

K954041G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES)K922187COMPACT SPACERK901803SYRINGE NEEDLE INTRODUCER

Related Devices (Code: KCD)

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.

K822258ESOPHAGEAL BOUGIESKelleher Corp.K800623JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUEPilling Co.

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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