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FDA 510(k)

GILTECH PLUS CONNECTING TUBE SET

K-Number: K983624 · 1999-03-18

ApplicantGiltech Plus, Inc.
Decision Date1999-03-18
Product CodeKDH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GILTECH PLUS CONNECTING TUBE SET is the device name listed in this FDA 510(k) record. The listed applicant is Giltech Plus, Inc.. It received FDA 510(k) clearance on 1999-03-18 under 510(k) number K983624. The device is classified under product code KDH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GILTECH PLUS CONNECTING TUBE SET?

GILTECH PLUS CONNECTING TUBE SET is a medical device that received FDA 510(k) clearance on 1999-03-18. The listed applicant is Giltech Plus, Inc.. The 510(k) number is K983624.

When did GILTECH PLUS CONNECTING TUBE SET receive FDA 510(k) clearance?

GILTECH PLUS CONNECTING TUBE SET received FDA 510(k) clearance on 1999-03-18, under 510(k) number K983624.

Who is the listed applicant for GILTECH PLUS CONNECTING TUBE SET?

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

What is the FDA product code for GILTECH PLUS CONNECTING TUBE SET?

The FDA product code for GILTECH PLUS CONNECTING TUBE SET is KDH.

Related Clinical Trials

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Other records listing Giltech Plus, 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.

K992094GILTECH PLUS HYDROGEL SKIN DRESSINGK992005GILTECH PLUS TRANSPARENT DRESSING

Related Devices (Code: KDH)

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.

K981286SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETSArmm, Inc.K971259COMBIPORT FLUID LAVAGE DEVICEB.Braun Medical, Inc.K962850TUM-E-VACEthox Corp.K951533EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KITBallard Medical ProductsK923497FLUSHING IRRIGATION SETOrion Life Systems, Inc.K920619TRI-MED GASTRIC LAVAGE SYSTEMTri-Med Specialties, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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