JEL BIOS 10 (CODE NAME RD-1801)— 510(k) K993136

Name: FDA 510(k) clearance K993136
Creator: U.S. Food and Drug Administration
Published: 1999-10-21

Substantially Equivalent

J.F. Jelenko & Co., Inc.

FDA 510(k) clearance K993136 for JEL BIOS 10 (CODE NAME RD-1801), Substantially Equivalent on 1999-10-21. Applicant: J.F. Jelenko & Co., Inc.. Device class: 2.

Clearance details

Applicant: J.F. Jelenko & Co., Inc.
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 1999-09-20
Decision date: 1999-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armonk, NY, US

Download summary PDF View on FDA.gov ↗

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