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FDA 510(k)

CLOSED WOUND DRAINAGE SYSTEMS

K-Number: K874645 · 1987-12-02

ApplicantHall Laboratories, Inc.
Decision Date1987-12-02
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLOSED WOUND DRAINAGE SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Hall Laboratories, Inc.. It received FDA 510(k) clearance on 1987-12-02 under 510(k) number K874645. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLOSED WOUND DRAINAGE SYSTEMS?

CLOSED WOUND DRAINAGE SYSTEMS is a medical device that received FDA 510(k) clearance on 1987-12-02. The listed applicant is Hall Laboratories, Inc.. The 510(k) number is K874645.

When did CLOSED WOUND DRAINAGE SYSTEMS receive FDA 510(k) clearance?

CLOSED WOUND DRAINAGE SYSTEMS received FDA 510(k) clearance on 1987-12-02, under 510(k) number K874645.

Who is the listed applicant for CLOSED WOUND DRAINAGE SYSTEMS?

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

What is the FDA product code for CLOSED WOUND DRAINAGE SYSTEMS?

The FDA product code for CLOSED WOUND DRAINAGE SYSTEMS is GCY.

Related Clinical Trials

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.

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Other records listing Hall 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.

K881514PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM

Related Devices (Code: GCY)

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.

K972703REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.K936223PRESSURE IRRIGATING SYSTEMLevel 1 Technologies, 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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