PDS-2000— 510(k) K902653

Substantially Equivalent

Intl. Equipment and Supply Corp.

FDA 510(k) clearance K902653 for PDS-2000, Substantially Equivalent on 1990-09-13. Applicant: Intl. Equipment and Supply Corp.. Device class: 1.

Clearance details

Applicant: Intl. Equipment and Supply Corp.
Product code: Code EIK
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1990-06-15
Decision date: 1990-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIK

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K851727 — 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA1985-07-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.