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FDA 510(k)

NON-WOVEN SPONGE

K-Number: K940901 · 1994-03-31

ApplicantMedical Insights, Inc.
Decision Date1994-03-31
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

NON-WOVEN SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Insights, Inc.. It received FDA 510(k) clearance on 1994-03-31 under 510(k) number K940901. 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 1994-03-31. The listed applicant is Medical Insights, Inc.. The 510(k) number is K940901.

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

NON-WOVEN SPONGE received FDA 510(k) clearance on 1994-03-31, under 510(k) number K940901.

Who is the listed applicant for NON-WOVEN SPONGE?

The FDA 510(k) record lists Medical Insights, 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.

Related Clinical Trials

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Other records listing Medical Insights, 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.

K940903TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGESK940904KITTNER DISSECTOR/PEANUT/CHERRY/STICK/TRIANGLE SPONGE/GAUZE ROSEBUDK924958BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY

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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