ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L— 510(k) K991946

Name: FDA 510(k) clearance K991946
Creator: U.S. Food and Drug Administration
Published: 1999-09-03

Substantially Equivalent

Sterilex Corp.

FDA 510(k) clearance K991946 for ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L, Substantially Equivalent on 1999-09-03. Applicant: Sterilex Corp.. Device class: 1.

Clearance details

Applicant: Sterilex Corp.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1999-06-09
Decision date: 1999-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Owins Mills, MD, US

Download summary PDF View on FDA.gov ↗

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