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FDA 510(k)

TRACHEOTOMY SPONGES

K-Number: K880909 · 1988-03-17

ApplicantOrmed Mfg., Inc.
Decision Date1988-03-17
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

TRACHEOTOMY SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Ormed Mfg., Inc.. It received FDA 510(k) clearance on 1988-03-17 under 510(k) number K880909. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHEOTOMY SPONGES?

TRACHEOTOMY SPONGES is a medical device that received FDA 510(k) clearance on 1988-03-17. The listed applicant is Ormed Mfg., Inc.. The 510(k) number is K880909.

When did TRACHEOTOMY SPONGES receive FDA 510(k) clearance?

TRACHEOTOMY SPONGES received FDA 510(k) clearance on 1988-03-17, under 510(k) number K880909.

Who is the listed applicant for TRACHEOTOMY SPONGES?

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

What is the FDA product code for TRACHEOTOMY SPONGES?

The FDA product code for TRACHEOTOMY SPONGES is EFQ.

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Other records listing Ormed Mfg., 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.

K931555ARTROMOT K2 CPMK882529BUTCHER STRUNG TONSIL SPONGEK882527GAUZE SPONGEK882528CYLINDRICAL SPONGEK882530TAPE STRUNG TONSIL SPONGEK880853CHERRY SPONGE

View all 23 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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