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FDA 510(k)

TOTAL CONTAINMENT DEVICE

K-Number: K913515 · 1994-05-26

ApplicantDenco
Decision Date1994-05-26
Product CodeKPF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TOTAL CONTAINMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Denco. It received FDA 510(k) clearance on 1994-05-26 under 510(k) number K913515. The device is classified under product code KPF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL CONTAINMENT DEVICE?

TOTAL CONTAINMENT DEVICE is a medical device that received FDA 510(k) clearance on 1994-05-26. The listed applicant is Denco. The 510(k) number is K913515.

When did TOTAL CONTAINMENT DEVICE receive FDA 510(k) clearance?

TOTAL CONTAINMENT DEVICE received FDA 510(k) clearance on 1994-05-26, under 510(k) number K913515.

Who is the listed applicant for TOTAL CONTAINMENT DEVICE?

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

What is the FDA product code for TOTAL CONTAINMENT DEVICE?

The FDA product code for TOTAL CONTAINMENT DEVICE is KPF.

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Related Devices (Code: KPF)

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.

K061515RENALSOFTBaxter Healthcare CorpK990953RENAL LINKBaxter Healthcare CorpK970989CYBERRENCybernius Medical , Ltd.K955762PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMFresenius USA, Inc.K875121AMICON EQUALINE FLUID BALANCE SYSTEMAmicon, Inc.K874020ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICEAbbott Laboratories

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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