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FDA 510(k)

EMERALD STERILE GAUZE SPONGE

K-Number: K961581 · 1996-05-28

ApplicantEmerald Medical, Inc.
Decision Date1996-05-28
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

EMERALD STERILE GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Emerald Medical, Inc.. It received FDA 510(k) clearance on 1996-05-28 under 510(k) number K961581. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMERALD STERILE GAUZE SPONGE?

EMERALD STERILE GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1996-05-28. The listed applicant is Emerald Medical, Inc.. The 510(k) number is K961581.

When did EMERALD STERILE GAUZE SPONGE receive FDA 510(k) clearance?

EMERALD STERILE GAUZE SPONGE received FDA 510(k) clearance on 1996-05-28, under 510(k) number K961581.

Who is the listed applicant for EMERALD STERILE GAUZE SPONGE?

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

What is the FDA product code for EMERALD STERILE GAUZE SPONGE?

The FDA product code for EMERALD STERILE GAUZE SPONGE 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 Emerald 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.

K030484SYNTHETICARE POWDERED VINYL EXAMINATION GLOVESK030483SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVESK964919EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM

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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