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FDA 510(k)

X-RAY GUAZE SPONGES

K-Number: K820106 · 1982-02-12

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

Device Summary

X-RAY GUAZE SPONGES 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 K820106. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-RAY GUAZE SPONGES?

X-RAY GUAZE SPONGES 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 K820106.

When did X-RAY GUAZE SPONGES receive FDA 510(k) clearance?

X-RAY GUAZE SPONGES received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820106.

Who is the listed applicant for X-RAY GUAZE SPONGES?

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 X-RAY GUAZE SPONGES?

The FDA product code for X-RAY GUAZE 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 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 TAPEK820108TOPPER SPONGESK820140WEBRIL CAST PADDINGK820155SPECIALIST CAST PADDING

View all 20 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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