ESPE KETAC-ENDO APLICAP— 510(k) K911061

Substantially Equivalent

H.A. Opotow Consulting

FDA 510(k) clearance K911061 for ESPE KETAC-ENDO APLICAP, Substantially Equivalent on 1992-01-03. Applicant: H.A. Opotow Consulting. Device class: 2.

Clearance details

Applicant: H.A. Opotow Consulting
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1991-03-11
Decision date: 1992-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Worth, FL, 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.