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FDA 510(k)

GAUZE SPONGE STERILE SPONGE

K-Number: K831183 · 1983-06-08

ApplicantDen Med, Inc.
Decision Date1983-06-08
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE SPONGE STERILE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Den Med, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831183. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE SPONGE STERILE SPONGE?

GAUZE SPONGE STERILE SPONGE is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Den Med, Inc.. The 510(k) number is K831183.

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

GAUZE SPONGE STERILE SPONGE received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831183.

Who is the listed applicant for GAUZE SPONGE STERILE SPONGE?

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

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

The FDA product code for GAUZE SPONGE STERILE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Den Med, 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.

K831182GAUZE SPONGE-NON-STERILE SPONGE

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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