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FDA 510(k)

GAUZE SPONGE 4X4X12 PLY

K-Number: K844726 · 1985-04-01

ApplicantApplied Medical
Decision Date1985-04-01
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE SPONGE 4X4X12 PLY is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical. It received FDA 510(k) clearance on 1985-04-01 under 510(k) number K844726. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE SPONGE 4X4X12 PLY?

GAUZE SPONGE 4X4X12 PLY is a medical device that received FDA 510(k) clearance on 1985-04-01. The listed applicant is Applied Medical. The 510(k) number is K844726.

When did GAUZE SPONGE 4X4X12 PLY receive FDA 510(k) clearance?

GAUZE SPONGE 4X4X12 PLY received FDA 510(k) clearance on 1985-04-01, under 510(k) number K844726.

Who is the listed applicant for GAUZE SPONGE 4X4X12 PLY?

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

What is the FDA product code for GAUZE SPONGE 4X4X12 PLY?

The FDA product code for GAUZE SPONGE 4X4X12 PLY is EFQ.

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Other records listing Applied Medical as applicant

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K202818Voyant Fine Fusion Device (EB230)K191866GelPOINT Mini Advanced Access PlatformK122619EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SETK070865EXPANDING VASCULAR SHEATHK003443SUCTION IRRIGATORK002915FLEXIBLE OCCLUSION SYSTEM

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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

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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