PAPCONE— 510(k) K083012

Substantially Equivalent

Otto Bock Pur Life Science GmbH

FDA 510(k) clearance K083012 for PAPCONE, Substantially Equivalent on 2009-04-09. Applicant: Otto Bock Pur Life Science GmbH. Device class: 2.

Clearance details

Applicant: Otto Bock Pur Life Science GmbH
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2008-10-09
Decision date: 2009-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Duderstadt, Lower Saxony, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code HHT

K182049 — exCellerator Cervical Collection Device2019-04-25
K153128 — Kolplast Cervical Sample Collection Kit2017-01-13
K141057 — DISPOSABLE CERVICAL BRUSH2015-05-14
K111681 — HISTOBRUSH2012-01-19
K081522 — BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY2008-12-05

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