AGALLOY, DISALLOY, EPSILON AND LAMBDA— 510(k) K942430

Name: FDA 510(k) clearance K942430
Creator: U.S. Food and Drug Administration
Published: 1994-07-14

Substantially Equivalent

Fen Dental Mfg., Inc.

FDA 510(k) clearance K942430 for AGALLOY, DISALLOY, EPSILON AND LAMBDA, Substantially Equivalent on 1994-07-14. Applicant: Fen Dental Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Fen Dental Mfg., Inc.
Product code: Code EJJ
Device class: Class 2
Regulation: 21 CFR 872.3070
Advisory panel: Dental
Date received: 1994-05-20
Decision date: 1994-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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