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FDA 510(k)

LAKE FOLEY CATHETERIZATION TRAY

K-Number: K883610 · 1988-10-12

ApplicantLake Medical Products, Inc.
Decision Date1988-10-12
Product CodeFCN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAKE FOLEY CATHETERIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Lake Medical Products, Inc.. It received FDA 510(k) clearance on 1988-10-12 under 510(k) number K883610. The device is classified under product code FCN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAKE FOLEY CATHETERIZATION TRAY?

LAKE FOLEY CATHETERIZATION TRAY is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Lake Medical Products, Inc.. The 510(k) number is K883610.

When did LAKE FOLEY CATHETERIZATION TRAY receive FDA 510(k) clearance?

LAKE FOLEY CATHETERIZATION TRAY received FDA 510(k) clearance on 1988-10-12, under 510(k) number K883610.

Who is the listed applicant for LAKE FOLEY CATHETERIZATION TRAY?

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

What is the FDA product code for LAKE FOLEY CATHETERIZATION TRAY?

The FDA product code for LAKE FOLEY CATHETERIZATION TRAY is FCN.

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Other records listing Lake Medical Products, 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.

K943162LAKE STAGEZERO(TM) AIR FLOTATION BEDK922730LAKE OSTOMY CARE SETK905053STAGE ZERO AIR FLOTATION BEDK901835LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)K902508LAKE MALE EXTERNAL CATHETERIZATION KITK902121LAKE GASTROSTOMY TUBE

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Related Devices (Code: FCN)

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.

K951443STANDARD FOLEY SYSTEM PAKTrinity Laboratories, Inc.K945258CATCO URINARY COLLECTION KITCatco Medical, Inc.K915166MICROCYCLERMedical Inventors Corp., Inc.K922346FEMALE URINE SAMPLING DEVICEMentor Corp.K890096BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAGMedical Inventors Corp., Inc.K883886DOUBLE CLOSED URINARY DRAINAGE SYSTEMKnight Medical, 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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