SATELEC PROPHY UNIT PU-2000— 510(k) K832673

Substantially Equivalent

Spelna, Inc.

FDA 510(k) clearance K832673 for SATELEC PROPHY UNIT PU-2000, Substantially Equivalent on 1983-10-19. Applicant: Spelna, Inc.. Device class: 1.

Clearance details

Applicant: Spelna, Inc.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1983-08-09
Decision date: 1983-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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.