• 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 K191208
Device Name Spectra Cashmere
Uzinmedicare Co.
56, Dongtansandan 5-Gil, Dongtan-Myeon
Hwaseong-Si,  KR 18487
Applicant Contact Nathan Ahn
Hyman, Phelps, & McNamara, P.C.
700 Thirteenth Street, N.W.
Suite 1200
Washington,  DC  20005
Correspondent Contact Adrienne R. Lenz
Regulation Number884.5160
Classification Product Code
Date Received05/06/2019
Decision Date 10/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No