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FDA 510(k)

DRAINAGE BAG, 4000 ML.

K-Number: K770557 · 1977-03-24

ApplicantConcord Laboratories, Inc.
Decision Date1977-03-24
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRAINAGE BAG, 4000 ML. is the device name listed in this FDA 510(k) record. The listed applicant is Concord Laboratories, Inc.. It received FDA 510(k) clearance on 1977-03-24 under 510(k) number K770557. 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 DRAINAGE BAG, 4000 ML.?

DRAINAGE BAG, 4000 ML. is a medical device that received FDA 510(k) clearance on 1977-03-24. The listed applicant is Concord Laboratories, Inc.. The 510(k) number is K770557.

When did DRAINAGE BAG, 4000 ML. receive FDA 510(k) clearance?

DRAINAGE BAG, 4000 ML. received FDA 510(k) clearance on 1977-03-24, under 510(k) number K770557.

Who is the listed applicant for DRAINAGE BAG, 4000 ML.?

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

What is the FDA product code for DRAINAGE BAG, 4000 ML.?

The FDA product code for DRAINAGE BAG, 4000 ML. is KNX.

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Other records listing Concord Laboratories, 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.

K883840DRI-VENT ARTERIAL BLOOD SAMPLING KITK871825MECONIUM SUCTION CATHETERK864535TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110K862039CONCORD CARE TRAYK854601SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATHK854327SUBCUTANEOUS TUNNELING NEEDLES & HANDLES

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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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