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FDA 510(k)

ZENEX MEDICAL, INC. GAUZE SPONGES

K-Number: K864298 · 1986-12-04

ApplicantZenex Medical, Inc.
Decision Date1986-12-04
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

ZENEX MEDICAL, INC. GAUZE SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Zenex Medical, Inc.. It received FDA 510(k) clearance on 1986-12-04 under 510(k) number K864298. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZENEX MEDICAL, INC. GAUZE SPONGES?

ZENEX MEDICAL, INC. GAUZE SPONGES is a medical device that received FDA 510(k) clearance on 1986-12-04. The listed applicant is Zenex Medical, Inc.. The 510(k) number is K864298.

When did ZENEX MEDICAL, INC. GAUZE SPONGES receive FDA 510(k) clearance?

ZENEX MEDICAL, INC. GAUZE SPONGES received FDA 510(k) clearance on 1986-12-04, under 510(k) number K864298.

Who is the listed applicant for ZENEX MEDICAL, INC. GAUZE SPONGES?

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

What is the FDA product code for ZENEX MEDICAL, INC. GAUZE SPONGES?

The FDA product code for ZENEX MEDICAL, INC. GAUZE SPONGES is EFQ.

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 Zenex Medical, 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.

K871160TRUETECH MEDICAL, INC. DENTURE CUPS

Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, 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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