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FDA 510(k)

BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE

K-Number: K911329 · 1991-05-28

ApplicantC.R. Bard, Inc.
Decision Date1991-05-28
Product CodeFOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1991-05-28 under 510(k) number K911329. The device is classified under product code FOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE?

BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE is a medical device that received FDA 510(k) clearance on 1991-05-28. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K911329.

When did BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE receive FDA 510(k) clearance?

BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE received FDA 510(k) clearance on 1991-05-28, under 510(k) number K911329.

Who is the listed applicant for BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE?

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

What is the FDA product code for BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE?

The FDA product code for BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE is FOC.

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Related Devices (Code: FOC)

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.

K950176PREMIE U-BAG URINE SPECIMEN COLLECTORHollister, Inc.K943752RIMECO MIDSTREAM URINE COLLECTORRimeco Products, Inc.K771368PORTABLE INFANT VENTILATORCavitron Corp.

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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