Bondek Polyglycolic Acid Synthetic Absorb. Suture

• • Terminated Z-2286-2010 FDA Unclassified (pre-2012) ·initiated 1 Feb 2010

  Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box.

510(k) Number

K905482 ↗

FDA Product Code

GAM

Device Class

Class II

Regulation

21 CFR Part 878.4493

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Pfizer Hospital Products Group, Inc. →