ORAL STEEL CARTRIDGE SYRINGE— 510(k) K941915

Name: FDA 510(k) clearance K941915
Creator: U.S. Food and Drug Administration
Published: 1995-01-26

Substantially Equivalent

Robert W. Bauer & Assoc., Inc.

FDA 510(k) clearance K941915 for ORAL STEEL CARTRIDGE SYRINGE, Substantially Equivalent on 1995-01-26. Applicant: Robert W. Bauer & Assoc., Inc.. Device class: 2.

Clearance details

Applicant: Robert W. Bauer & Assoc., Inc.
Product code: Code EJI
Device class: Class 2
Regulation: 21 CFR 872.6770
Advisory panel: Dental
Date received: 1994-04-19
Decision date: 1995-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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