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FDA 510(k)

CLOSED SYS. DRAINAGE BAGS & TRAYS

K-Number: K832822 · 1983-10-14

ApplicantMedline Industries, Inc.
Decision Date1983-10-14
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLOSED SYS. DRAINAGE BAGS & TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832822. 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 CLOSED SYS. DRAINAGE BAGS & TRAYS?

CLOSED SYS. DRAINAGE BAGS & TRAYS is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Medline Industries, Inc.. The 510(k) number is K832822.

When did CLOSED SYS. DRAINAGE BAGS & TRAYS receive FDA 510(k) clearance?

CLOSED SYS. DRAINAGE BAGS & TRAYS received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832822.

Who is the listed applicant for CLOSED SYS. DRAINAGE BAGS & TRAYS?

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

What is the FDA product code for CLOSED SYS. DRAINAGE BAGS & TRAYS?

The FDA product code for CLOSED SYS. DRAINAGE BAGS & TRAYS is KNX.

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Other records listing Medline Industries, Inc. as applicant

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K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)K222665Medline UNITE® Ankle Fusion Plating SystemK213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeK212911Konig Mogen ClampK220565Hudson RCI Triflo II Incentive Deep Breathing Exerciser

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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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