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 K252939
Device Name COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
Applicant
Cotton High Tech S.L.
Colònia La Rabeia S/N
Balsareny,  ES 08660
Applicant Contact Míriam Carrero
Correspondent
Cotton High Tech S.L.
Colònia La Rabeia S/N
Balsareny,  ES 08660
Correspondent Contact Míriam Carrero
Regulation Number884.5470
Classification Product Code
HEB  
Date Received09/15/2025
Decision Date 10/09/2025
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
Predetermined Change
Control Plan Authorized		 No
-
-