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FDA 510(k)

UNIVERSAL FIX-A-PLATE

K-Number: K833057 · 1984-02-27

ApplicantLaurentian Laboratories
Decision Date1984-02-27
Product CodeEBO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL FIX-A-PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Laurentian Laboratories. It received FDA 510(k) clearance on 1984-02-27 under 510(k) number K833057. The device is classified under product code EBO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL FIX-A-PLATE?

UNIVERSAL FIX-A-PLATE is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is Laurentian Laboratories. The 510(k) number is K833057.

When did UNIVERSAL FIX-A-PLATE receive FDA 510(k) clearance?

UNIVERSAL FIX-A-PLATE received FDA 510(k) clearance on 1984-02-27, under 510(k) number K833057.

Who is the listed applicant for UNIVERSAL FIX-A-PLATE?

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

What is the FDA product code for UNIVERSAL FIX-A-PLATE?

The FDA product code for UNIVERSAL FIX-A-PLATE is EBO.

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 Laurentian Laboratories 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.

K833056UNIVERSAL LINE-A-PLATE

Related Devices (Code: EBO)

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.

K850927COMPLETE DENTURE REPAIR KITTooth Aid Lab, Inc.K844480DENTAL ORAL CARE SYSTEMS & COMPONENTSAdvanced Bio Systems, Inc.K833056UNIVERSAL LINE-A-PLATELaurentian LaboratoriesK820245SAFE TDENTProfessional Dental StudiosK820685DENTURE ADJUSTMENT KITCamdent LaboratoriesK770091EMERGENCY FAST-FIX DENTURE REPAIR KITMr. Clarence Hurst

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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