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FDA 510(k)

THE CHICAGO GULLET

K-Number: K813132 · 1982-01-07

ApplicantUniversal Prosthetics, Inc.
Decision Date1982-01-07
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE CHICAGO GULLET is the device name listed in this FDA 510(k) record. The listed applicant is Universal Prosthetics, Inc.. It received FDA 510(k) clearance on 1982-01-07 under 510(k) number K813132. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE CHICAGO GULLET?

THE CHICAGO GULLET is a medical device that received FDA 510(k) clearance on 1982-01-07. The listed applicant is Universal Prosthetics, Inc.. The 510(k) number is K813132.

When did THE CHICAGO GULLET receive FDA 510(k) clearance?

THE CHICAGO GULLET received FDA 510(k) clearance on 1982-01-07, under 510(k) number K813132.

Who is the listed applicant for THE CHICAGO GULLET?

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

What is the FDA product code for THE CHICAGO GULLET?

The FDA product code for THE CHICAGO GULLET is KNT.

Related Clinical Trials

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Other records listing Universal Prosthetics, 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.

K832366ZOLLER BURNED LIP CONFORMERK811428NORTHWESTERN VOICE RESTORATION KIT

Related Devices (Code: KNT)

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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

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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