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FDA 510(k)

BALDUR NON-STERILE COTTON SPONGES

K-Number: K974347 · 1998-02-10

ApplicantBaldur Systems Corp.
Decision Date1998-02-10
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

BALDUR NON-STERILE COTTON SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Baldur Systems Corp.. It received FDA 510(k) clearance on 1998-02-10 under 510(k) number K974347. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BALDUR NON-STERILE COTTON SPONGES?

BALDUR NON-STERILE COTTON SPONGES is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Baldur Systems Corp.. The 510(k) number is K974347.

When did BALDUR NON-STERILE COTTON SPONGES receive FDA 510(k) clearance?

BALDUR NON-STERILE COTTON SPONGES received FDA 510(k) clearance on 1998-02-10, under 510(k) number K974347.

Who is the listed applicant for BALDUR NON-STERILE COTTON SPONGES?

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

What is the FDA product code for BALDUR NON-STERILE COTTON SPONGES?

The FDA product code for BALDUR NON-STERILE COTTON SPONGES 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.

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Other records listing Baldur Systems 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.

K981823OPERATING ROOM TOWELSK892684PATIENT EXAMINATION GLOVES (LATEX)K891728LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD)K891727LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD)K891726VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)

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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