• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name pump, breast, powered
510(k) Number K200508
Device Name Pump In Style
Medela LLC
1101 Corporate Drive
McHenry,  IL  60050
Applicant Contact PJ Pasia
Medela LLC
1101 Corporate Drive
McHenry,  IL  60050
Correspondent Contact PJ Pasia
Regulation Number884.5160
Classification Product Code
Date Received03/02/2020
Decision Date 06/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No