• 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 K190810
Device Name OPERA, OPERA eco
Unimom Co.
110-19, Gajangsaneopseobuk-ro
Osan-si,  KR 18102
Applicant Contact Sang-Hyun Hong
Unimom Co.
110-19, Gajangsaneopseobuk-ro
Osan-si,  KR 18102
Correspondent Contact Sang-Hyun Hong
Regulation Number884.5160
Classification Product Code
Date Received03/29/2019
Decision Date 08/30/2019
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