ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285— 510(k) K994211

Name: FDA 510(k) clearance K994211
Creator: U.S. Food and Drug Administration
Published: 2000-02-04

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K994211 for ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285, Substantially Equivalent on 2000-02-04. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1999-12-14
Decision date: 2000-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, 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.