EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER— 510(k) K963685

Name: FDA 510(k) clearance K963685
Creator: U.S. Food and Drug Administration
Published: 1996-10-11

Substantially Equivalent

North Eos Industries, Inc.

FDA 510(k) clearance K963685 for EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER, Substantially Equivalent on 1996-10-11. Applicant: North Eos Industries, Inc.. Device class: 2.

Clearance details

Applicant: North Eos Industries, Inc.
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1996-09-03
Decision date: 1996-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung Hsien 423, TW

Download summary PDF View on FDA.gov ↗

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