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FDA 510(k)

URINARY CATHETER CARE TRAYS #3700&3710

K-Number: K801787 · 1980-10-21

ApplicantThe Healthcare Group Laboratories, Inc.
Decision Date1980-10-21
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINARY CATHETER CARE TRAYS #3700&3710 is the device name listed in this FDA 510(k) record. The listed applicant is The Healthcare Group Laboratories, Inc.. It received FDA 510(k) clearance on 1980-10-21 under 510(k) number K801787. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINARY CATHETER CARE TRAYS #3700&3710?

URINARY CATHETER CARE TRAYS #3700&3710 is a medical device that received FDA 510(k) clearance on 1980-10-21. The listed applicant is The Healthcare Group Laboratories, Inc.. The 510(k) number is K801787.

When did URINARY CATHETER CARE TRAYS #3700&3710 receive FDA 510(k) clearance?

URINARY CATHETER CARE TRAYS #3700&3710 received FDA 510(k) clearance on 1980-10-21, under 510(k) number K801787.

Who is the listed applicant for URINARY CATHETER CARE TRAYS #3700&3710?

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

What is the FDA product code for URINARY CATHETER CARE TRAYS #3700&3710?

The FDA product code for URINARY CATHETER CARE TRAYS #3700&3710 is KOD.

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Other records listing The Healthcare Group 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.

K850035EMPTY SOLUTION TRANSFER CONTAINERK842170EMPTY SOLUTION TRANSFER CONTAINERK842091DISPOS. ACU-CUT SOFT TISSUE BIOPSYK840742RIGHT ATRIAL CATHETERK830299SOLUTION TRANSFER CONTAINERK822307ADHESIVE SPRAY #4050-4060

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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