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FDA 510(k)

GUAZE SPONGES, PLAIN

K-Number: K820107 · 1982-02-12

ApplicantStan-Pak Ent.
Decision Date1982-02-12
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GUAZE SPONGES, PLAIN is the device name listed in this FDA 510(k) record. The listed applicant is Stan-Pak Ent.. It received FDA 510(k) clearance on 1982-02-12 under 510(k) number K820107. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUAZE SPONGES, PLAIN?

GUAZE SPONGES, PLAIN is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is Stan-Pak Ent.. The 510(k) number is K820107.

When did GUAZE SPONGES, PLAIN receive FDA 510(k) clearance?

GUAZE SPONGES, PLAIN received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820107.

Who is the listed applicant for GUAZE SPONGES, PLAIN?

The FDA 510(k) record lists Stan-Pak Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUAZE SPONGES, PLAIN?

The FDA product code for GUAZE SPONGES, PLAIN 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 Stan-Pak Ent. 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.

K823058DOSOMETRIC RELEASE STERILIZATIONK820100FROSTED GLASS SLIDESK820099TRACH TAPEK820140WEBRIL CAST PADDINGK820155SPECIALIST CAST PADDINGK820106X-RAY GUAZE SPONGES

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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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