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FDA 510(k)

PROTEC GAUZE SPONGE

K-Number: K955321 · 1995-12-19

ApplicantDerivados DE Gasa, S.A. DE C.V.
Decision Date1995-12-19
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

PROTEC GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Derivados DE Gasa, S.A. DE C.V.. It received FDA 510(k) clearance on 1995-12-19 under 510(k) number K955321. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTEC GAUZE SPONGE?

PROTEC GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1995-12-19. The listed applicant is Derivados DE Gasa, S.A. DE C.V.. The 510(k) number is K955321.

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

PROTEC GAUZE SPONGE received FDA 510(k) clearance on 1995-12-19, under 510(k) number K955321.

Who is the listed applicant for PROTEC GAUZE SPONGE?

The FDA 510(k) record lists Derivados DE Gasa, S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTEC GAUZE SPONGE?

The FDA product code for PROTEC 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.

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 Derivados DE Gasa, S.A. DE C.V. 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.

K955322PROTEC X-RAY DETECTABLE GAUZE 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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