SUNLITE 1275— 510(k) K951465

Substantially Equivalent

Fen Dental Mfg., Inc.

FDA 510(k) clearance K951465 for SUNLITE 1275, Substantially Equivalent on 1995-05-31. Applicant: Fen Dental Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Fen Dental Mfg., Inc.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 1995-03-30
Decision date: 1995-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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.