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)

B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE

K-Number: K900767 · 1990-05-04

Decision Date1990-05-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Beacon Laboratories, Inc.. It received FDA 510(k) clearance on 1990-05-04 under 510(k) number K900767. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE?

B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE is a medical device that received FDA 510(k) clearance on 1990-05-04. The listed applicant is Beacon Laboratories, Inc.. The 510(k) number is K900767.

When did B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE receive FDA 510(k) clearance?

B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE received FDA 510(k) clearance on 1990-05-04, under 510(k) number K900767.

Who is the listed applicant for B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE?

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

What is the FDA product code for B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE?

The FDA product code for B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE is GEI.

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 Beacon 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 18 devices →

Related Devices (Code: GEI)

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.

↑