Playtex Embrace Petite Breast Pump

• • Terminated Z-1336-2014 FDA Class II ·initiated 18 Mar 2014

  Some of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock.

510(k) Number

K061013 ↗

FDA Product Code

HGX

Device Class

Class II

Regulation

21 CFR Part 884.5160

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Playtex Deodorant Tampons, Model 34702

  Class II

  FDA 510(k) K020202 Active Cleared 12 Mar 2002

• Playtex Ultimates Silk Glide Tampons #23094

  Class II

  FDA 510(k) K944155 Active Cleared 9 Feb 1995

• Playtex Ultimates Silk Glide Tampons #22994

  Class II

  FDA 510(k) K944154 Active Cleared 9 Feb 1995

• Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons

  Class II

  FDA 510(k) K070745 Active Cleared 13 Apr 2007

• Playtex Deodorant Tampons, Model 34802

  Class II

  FDA 510(k) K020200 Active Cleared 13 Mar 2002

• Playtex Slimfit Tampons

  Class II

  FDA 510(k) K961870 Active Cleared 19 Jun 1996

See all devices from Playtex Products, Inc. →