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FDA 510(k)

CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER

K-Number: K041038 · 2004-12-21

ApplicantChurchill Medical Systems, Inc.
Decision Date2004-12-21
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Churchill Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-12-21 under 510(k) number K041038. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER?

CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER is a medical device that received FDA 510(k) clearance on 2004-12-21. The listed applicant is Churchill Medical Systems, Inc.. The 510(k) number is K041038.

When did CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER receive FDA 510(k) clearance?

CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER received FDA 510(k) clearance on 2004-12-21, under 510(k) number K041038.

Who is the listed applicant for CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER?

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

What is the FDA product code for CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER?

The FDA product code for CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER is KPE.

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Other records listing Churchill Medical Systems, 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.

K021395MODIFICATION TO 30 EXTENSION SETK013949UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTORK020544WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GAK013950VENTED VIAL ACCESS DEVICEK012157CHURCHILL MEDICAL SYSTEMS STOPCOCKK011888PRESSURE ACTIVATED CHECK VALVE

View all 12 devices →

Related Devices (Code: KPE)

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.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AGK252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.

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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