CURELLE— 510(k) K915491

Substantially Equivalent

Bioteque Corp.

FDA 510(k) clearance K915491 for CURELLE, Substantially Equivalent on 1992-11-04. Applicant: Bioteque Corp.. Device class: 2.

Clearance details

Applicant: Bioteque Corp.
Product code: Code HHK
Device class: Class 2
Regulation: 21 CFR 884.1175
Advisory panel: Obstetrics/Gynecology
Date received: 1991-12-06
Decision date: 1992-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Levittown, PA, 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.