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FDA 510(k)

INTECARE PEDIATRIC URINE COLLECTOR

K-Number: K871789 · 1987-08-10

ApplicantMercury Enterprises, Inc.
Decision Date1987-08-10
Product CodeFFH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTECARE PEDIATRIC URINE COLLECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Mercury Enterprises, Inc.. It received FDA 510(k) clearance on 1987-08-10 under 510(k) number K871789. The device is classified under product code FFH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTECARE PEDIATRIC URINE COLLECTOR?

INTECARE PEDIATRIC URINE COLLECTOR is a medical device that received FDA 510(k) clearance on 1987-08-10. The listed applicant is Mercury Enterprises, Inc.. The 510(k) number is K871789.

When did INTECARE PEDIATRIC URINE COLLECTOR receive FDA 510(k) clearance?

INTECARE PEDIATRIC URINE COLLECTOR received FDA 510(k) clearance on 1987-08-10, under 510(k) number K871789.

Who is the listed applicant for INTECARE PEDIATRIC URINE COLLECTOR?

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

What is the FDA product code for INTECARE PEDIATRIC URINE COLLECTOR?

The FDA product code for INTECARE PEDIATRIC URINE COLLECTOR is FFH.

Related Clinical Trials

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Other records listing Mercury Enterprises, 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.

K885342GENNY DENNY IV SHIELDK862722TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE

Related Devices (Code: FFH)

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.

K905016PEDIATRIC AND INFANT CATH KITSDavol, Inc.K896581PEDIATRIC DRAIN BAGLaytech Medical Co.

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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