DOWN PAK— 510(k) K070246

Substantially Equivalent

Endo Twinn B.V.

FDA 510(k) clearance K070246 for DOWN PAK, Substantially Equivalent on 2007-02-16. Applicant: Endo Twinn B.V.. Device class: 1.

Clearance details

Applicant: Endo Twinn B.V.
Product code: Code EKM
Device class: Class 1
Regulation: 21 CFR 872.3850
Advisory panel: Dental
Date received: 2007-01-25
Decision date: 2007-02-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Amsterdam, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKM

K073369 — EI DOWNPAK BARRIER SLEEVES2008-02-27
K051573 — TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)2006-06-26
K042870 — ENDO TWINN2005-01-11
K023819 — FIBERFILL SGP2003-03-26
K971641 — ANTIBACTERIAL GUTTA PERCHA1997-07-21

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