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 K802760
Device Name PETAL SOFT PLASTIC APPLICATOR TAMPAX
Applicant
Tampax, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Tampax, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number884.5470
Classification Product Code
HEB  
Date Received11/05/1980
Decision Date 01/12/1981
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
-
-