SWIRL PROPHYLAXIS PASTE— 510(k) K903986

Substantially Equivalent

Bio-Medica Concepts

FDA 510(k) clearance K903986 for SWIRL PROPHYLAXIS PASTE, Substantially Equivalent on 1991-03-28. Applicant: Bio-Medica Concepts. Device class: 1.

Clearance details

Applicant: Bio-Medica Concepts
Product code: Code EJR
Device class: Class 1
Regulation: 21 CFR 872.6030
Advisory panel: Dental
Date received: 1990-08-29
Decision date: 1991-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.