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FDA 510(k)

DYNAREX TRACHEOSTOMY SPONGE

K-Number: K983348 · 1998-12-11

ApplicantDynarex Corp.
Decision Date1998-12-11
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

DYNAREX TRACHEOSTOMY SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corp.. It received FDA 510(k) clearance on 1998-12-11 under 510(k) number K983348. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAREX TRACHEOSTOMY SPONGE?

DYNAREX TRACHEOSTOMY SPONGE is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Dynarex Corp.. The 510(k) number is K983348.

When did DYNAREX TRACHEOSTOMY SPONGE receive FDA 510(k) clearance?

DYNAREX TRACHEOSTOMY SPONGE received FDA 510(k) clearance on 1998-12-11, under 510(k) number K983348.

Who is the listed applicant for DYNAREX TRACHEOSTOMY SPONGE?

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

What is the FDA product code for DYNAREX TRACHEOSTOMY SPONGE?

The FDA product code for DYNAREX TRACHEOSTOMY SPONGE is EFQ.

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Other records listing Dynarex Corp. 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.

K052743DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921K052314DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGEK012816DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414K012957TOWEL DRAPE, MODELS 4409, 4410K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-BK991695DYNAREX NON-WOVEN 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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