ACCELLON CERVICAL BIOSAMPLER— 510(k) K911432

Substantially Equivalent

Medscand AB

FDA 510(k) clearance K911432 for ACCELLON CERVICAL BIOSAMPLER, Substantially Equivalent on 1993-09-03. Applicant: Medscand AB. Device class: 2.

Clearance details

Applicant: Medscand AB
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1991-04-02
Decision date: 1993-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malmo, SE

Download summary PDF View on FDA.gov ↗

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