SOFTPAP CERVICAL CELL COLLECTOR— 510(k) K072381

Substantially Equivalent

Cytocore, Inc.

FDA 510(k) clearance K072381 for SOFTPAP CERVICAL CELL COLLECTOR, Substantially Equivalent on 2008-01-30. Applicant: Cytocore, Inc.. Device class: 2.

Clearance details

Applicant: Cytocore, Inc.
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2007-08-24
Decision date: 2008-01-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Chicago, 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.