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FDA 510(k)

GAUZE SPONGES USP TYPE VII

K-Number: K861215 · 1986-04-17

ApplicantSelomas, Inc.
Decision Date1986-04-17
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE SPONGES USP TYPE VII is the device name listed in this FDA 510(k) record. The listed applicant is Selomas, Inc.. It received FDA 510(k) clearance on 1986-04-17 under 510(k) number K861215. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE SPONGES USP TYPE VII?

GAUZE SPONGES USP TYPE VII is a medical device that received FDA 510(k) clearance on 1986-04-17. The listed applicant is Selomas, Inc.. The 510(k) number is K861215.

When did GAUZE SPONGES USP TYPE VII receive FDA 510(k) clearance?

GAUZE SPONGES USP TYPE VII received FDA 510(k) clearance on 1986-04-17, under 510(k) number K861215.

Who is the listed applicant for GAUZE SPONGES USP TYPE VII?

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

What is the FDA product code for GAUZE SPONGES USP TYPE VII?

The FDA product code for GAUZE SPONGES USP TYPE VII 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 Selomas, 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.

K821258SELOPORK821260VITOFITK821259VITASANK821490SILKAFIX ADHESIVE PLASTERK821257SELOFIXK812501OPRAFLEX

View all 7 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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