HEATED GUTTA PERCHA DELIVERY SYSTEM— 510(k) K832654

Name: FDA 510(k) clearance K832654
Creator: U.S. Food and Drug Administration
Published: 1983-09-26

Substantially Equivalent

Unitek Corp.

FDA 510(k) clearance K832654 for HEATED GUTTA PERCHA DELIVERY SYSTEM, Substantially Equivalent on 1983-09-26. Applicant: Unitek Corp.. Device class: 1.

Clearance details

Applicant: Unitek Corp.
Product code: Code EKM
Device class: Class 1
Regulation: 21 CFR 872.3850
Advisory panel: Dental
Date received: 1983-08-08
Decision date: 1983-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKM

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K042870 — ENDO TWINN2005-01-11
K023819 — FIBERFILL SGP2003-03-26

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K924645 — TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS1992-11-25

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