Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Tampon, Menstrual, Unscented
510(k) Number K190218
Device Name Unscented Menstrual Tampon
Applicant
Qingdao Youjia Hygiene Technology Co., Ltd
No. 778 Mingyue Road, Huangdao Zone
Qingdao,  CN 266400
Applicant Contact Huiying Zhao
Correspondent
Shenzhen Joyantech Consulting Co., Ltd
Room 1122, No.55 Shizhou Middle Road, Nanshan District
Shenzhen,  CN gd755
Correspondent Contact Jessie You
Regulation Number884.5470
Classification Product Code
HEB  
Date Received02/04/2019
Decision Date 05/09/2019
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
-
-