Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NORTHWESTERN VOICE RESTORATION KIT

K-Number: K811428 · 1981-06-16

ApplicantUniversal Prosthetics, Inc.
Decision Date1981-06-16
Product CodeKAC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NORTHWESTERN VOICE RESTORATION KIT 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 1981-06-16 under 510(k) number K811428. The device is classified under product code KAC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTHWESTERN VOICE RESTORATION KIT?

NORTHWESTERN VOICE RESTORATION KIT is a medical device that received FDA 510(k) clearance on 1981-06-16. The listed applicant is Universal Prosthetics, Inc.. The 510(k) number is K811428.

When did NORTHWESTERN VOICE RESTORATION KIT receive FDA 510(k) clearance?

NORTHWESTERN VOICE RESTORATION KIT received FDA 510(k) clearance on 1981-06-16, under 510(k) number K811428.

Who is the listed applicant for NORTHWESTERN VOICE RESTORATION KIT?

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 NORTHWESTERN VOICE RESTORATION KIT?

The FDA product code for NORTHWESTERN VOICE RESTORATION KIT is KAC.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 CONFORMERK813132THE CHICAGO GULLET

Related Devices (Code: KAC)

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.

K901377BARTON-MAYO TRACHEOSTOMA BUTTONMedical Innovations International, Inc.K873992LARYNGECTOMY TUBEPortex, Inc.K821993SHILEY LARYNGECTOMY TUBEShiley, 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.

↑