SIMPLEX AIRBRATOR— 510(k) K970249

Name: FDA 510(k) clearance K970249
Creator: U.S. Food and Drug Administration
Published: 1997-05-07

Substantially Equivalent

Simplex Medical Systems, Inc.

FDA 510(k) clearance K970249 for SIMPLEX AIRBRATOR, Substantially Equivalent on 1997-05-07. Applicant: Simplex Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Simplex Medical Systems, Inc.
Product code: Code KOJ
Device class: Class 2
Regulation: 21 CFR 872.6080
Advisory panel: Dental
Date received: 1997-01-22
Decision date: 1997-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hallandale, FL, US

Download summary PDF View on FDA.gov ↗

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