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FDA 510(k)

NON-WOVEN SPONGE

K-Number: K935931 · 1994-01-14

ApplicantMcneil Healthcare, Inc.
Decision Date1994-01-14
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

NON-WOVEN SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Mcneil Healthcare, Inc.. It received FDA 510(k) clearance on 1994-01-14 under 510(k) number K935931. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-WOVEN SPONGE?

NON-WOVEN SPONGE is a medical device that received FDA 510(k) clearance on 1994-01-14. The listed applicant is Mcneil Healthcare, Inc.. The 510(k) number is K935931.

When did NON-WOVEN SPONGE receive FDA 510(k) clearance?

NON-WOVEN SPONGE received FDA 510(k) clearance on 1994-01-14, under 510(k) number K935931.

Who is the listed applicant for NON-WOVEN SPONGE?

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

What is the FDA product code for NON-WOVEN SPONGE?

The FDA product code for NON-WOVEN SPONGE is EFQ.

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Other records listing Mcneil Healthcare, 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.

K935930NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSINGK935883NEUROLOGICAL SPONGESK935993SURGICAL SPONGE X-RAY DETECTABLEK935934NON ADHERANT BURN PADSK935881SPECIALTY SPONGESK935910X-RAY PACKING SPONGE

View all 19 devices →

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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