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FDA 510(k)

MEDIFLEX DRAINAGE BAG

K-Number: K843126 · 1984-10-04

ApplicantMediflex Intl.
Decision Date1984-10-04
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDIFLEX DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Mediflex Intl.. It received FDA 510(k) clearance on 1984-10-04 under 510(k) number K843126. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIFLEX DRAINAGE BAG?

MEDIFLEX DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1984-10-04. The listed applicant is Mediflex Intl.. The 510(k) number is K843126.

When did MEDIFLEX DRAINAGE BAG receive FDA 510(k) clearance?

MEDIFLEX DRAINAGE BAG received FDA 510(k) clearance on 1984-10-04, under 510(k) number K843126.

Who is the listed applicant for MEDIFLEX DRAINAGE BAG?

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

What is the FDA product code for MEDIFLEX DRAINAGE BAG?

The FDA product code for MEDIFLEX DRAINAGE BAG is KNX.

Related Clinical Trials

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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Other records listing Mediflex Intl. 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.

K915140PRIMARY DRESSING TRAYK900841HEMODIALYSIS TRANSDUCER PROTECTORK891077MEDIVERSE PARENTERAL NUTRITION BAGK884243BLOOD TUBING SETK863496MEDIFLEX TRANSDUCER PROTECTORK855039MEDIFLEX INJECTION CAP

View all 9 devices →

Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.

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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