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FDA 510(k)

STARRYSHINE GAUZE SPONGE

K-Number: K983450 · 1998-11-12

ApplicantT.C. Dental Products, Inc.
Decision Date1998-11-12
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

STARRYSHINE GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is T.C. Dental Products, Inc.. It received FDA 510(k) clearance on 1998-11-12 under 510(k) number K983450. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARRYSHINE GAUZE SPONGE?

STARRYSHINE GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1998-11-12. The listed applicant is T.C. Dental Products, Inc.. The 510(k) number is K983450.

When did STARRYSHINE GAUZE SPONGE receive FDA 510(k) clearance?

STARRYSHINE GAUZE SPONGE received FDA 510(k) clearance on 1998-11-12, under 510(k) number K983450.

Who is the listed applicant for STARRYSHINE GAUZE SPONGE?

The FDA 510(k) record lists T.C. Dental Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STARRYSHINE GAUZE SPONGE?

The FDA product code for STARRYSHINE GAUZE SPONGE is EFQ.

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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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