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FDA 510(k)

GAUZE SPONGE,STERILE 2'S

K-Number: K912779 · 1991-09-30

ApplicantKeilei Intl., Inc.
Decision Date1991-09-30
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GAUZE SPONGE,STERILE 2'S is the device name listed in this FDA 510(k) record. The listed applicant is Keilei Intl., Inc.. It received FDA 510(k) clearance on 1991-09-30 under 510(k) number K912779. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE SPONGE,STERILE 2'S?

GAUZE SPONGE,STERILE 2'S is a medical device that received FDA 510(k) clearance on 1991-09-30. The listed applicant is Keilei Intl., Inc.. The 510(k) number is K912779.

When did GAUZE SPONGE,STERILE 2'S receive FDA 510(k) clearance?

GAUZE SPONGE,STERILE 2'S received FDA 510(k) clearance on 1991-09-30, under 510(k) number K912779.

Who is the listed applicant for GAUZE SPONGE,STERILE 2'S?

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

What is the FDA product code for GAUZE SPONGE,STERILE 2'S?

The FDA product code for GAUZE SPONGE,STERILE 2'S is NAB.

Related Clinical Trials

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Other records listing Keilei Intl., 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.

K913779BANDAGE ROLL, GAUZEK913575GAUZE PACKING, SURGICAL STERILE AND NON-STERILEK895372X-RAY DETECTABLE GAUZE SPONGEK895086GAUZE SPONGE

Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, 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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