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)

CUTTER TUNGSTEN CARBIDE BURS

K-Number: K770469 · 1977-03-16

Decision Date1977-03-16
Product CodeEJL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CUTTER TUNGSTEN CARBIDE BURS is the device name listed in this FDA 510(k) record. The listed applicant is Cutter Laboratories, Inc.. It received FDA 510(k) clearance on 1977-03-16 under 510(k) number K770469. The device is classified under product code EJL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUTTER TUNGSTEN CARBIDE BURS?

CUTTER TUNGSTEN CARBIDE BURS is a medical device that received FDA 510(k) clearance on 1977-03-16. The listed applicant is Cutter Laboratories, Inc.. The 510(k) number is K770469.

When did CUTTER TUNGSTEN CARBIDE BURS receive FDA 510(k) clearance?

CUTTER TUNGSTEN CARBIDE BURS received FDA 510(k) clearance on 1977-03-16, under 510(k) number K770469.

Who is the listed applicant for CUTTER TUNGSTEN CARBIDE BURS?

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

What is the FDA product code for CUTTER TUNGSTEN CARBIDE BURS?

The FDA product code for CUTTER TUNGSTEN CARBIDE BURS is EJL.

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.

Other records listing Cutter Laboratories, 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.

View all 39 devices →

Related Devices (Code: EJL)

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.

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.

↑