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 K122603
Device Name ONTEX AND OTHER PROPRIETARY NAMES
Applicant
Ontex Bvba
30 Neck Rd.
Old Lyme,  CT  06371
Applicant Contact ROBERT J STAAB
Correspondent
Ontex Bvba
30 Neck Rd.
Old Lyme,  CT  06371
Correspondent Contact ROBERT J STAAB
Regulation Number884.5470
Classification Product Code
HEB  
Date Received08/27/2012
Decision Date 12/19/2012
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
Predetermined Change
Control Plan Authorized		 No
-
-