BARD PERFIX LIGHT PLUG - 0117080

• • Terminated Z-0191-2015 FDA Class II ·initiated 8 Oct 2014

  The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug.

510(k) Number

K092032 ↗

FDA Product Code

FTL

Models / Variants

0117050

0117060

0117070

0117080

0117150

0117160

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Davol Inc., Sub. C. R. Bard, Inc. →