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FDA 510(k)

BAG, URINE COLLECTION, CLOSED SYSTEM

K-Number: K760105 · 1976-10-07

ApplicantConcord Laboratories, Inc.
Decision Date1976-10-07
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BAG, URINE COLLECTION, CLOSED SYSTEM 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 1976-10-07 under 510(k) number K760105. 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 BAG, URINE COLLECTION, CLOSED SYSTEM?

BAG, URINE COLLECTION, CLOSED SYSTEM is a medical device that received FDA 510(k) clearance on 1976-10-07. The listed applicant is Concord Laboratories, Inc.. The 510(k) number is K760105.

When did BAG, URINE COLLECTION, CLOSED SYSTEM receive FDA 510(k) clearance?

BAG, URINE COLLECTION, CLOSED SYSTEM received FDA 510(k) clearance on 1976-10-07, under 510(k) number K760105.

Who is the listed applicant for BAG, URINE COLLECTION, CLOSED SYSTEM?

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 BAG, URINE COLLECTION, CLOSED SYSTEM?

The FDA product code for BAG, URINE COLLECTION, CLOSED SYSTEM 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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