• 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 K191109
Device Name Spectra Q
Uzinmedicare Co.
Rm 105, Joongang Induspia V, Sagimakgolo 137,
Jungwon-gu, Seongnam-Si, Gyeonggi-do, 13202, South Korea
Seongnam-si,  KR 13202
Applicant Contact Jisun Lee
GMS Consulting Co., Ltd.
34, Sangamsan-ro, Mapo-gu, Seoul, Republic of Korea
Seoul-si,  KR 03909
Correspondent Contact Dogyun Im
Regulation Number884.5160
Classification Product Code
Date Received04/26/2019
Decision Date 01/22/2020
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