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 Pad, Menstrual, Unscented
510(k) Number K953633
Device Name UNSCENTED MENSTRUAL PAD
Applicant
Tendasoft, Inc.
1001 Vision Dr.
Van Wert,  OH  45891
Applicant Contact DEREK DAFOE
Correspondent
Tendasoft, Inc.
1001 Vision Dr.
Van Wert,  OH  45891
Correspondent Contact DEREK DAFOE
Regulation Number884.5435
Classification Product Code
HHD  
Date Received08/04/1995
Decision Date 11/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-