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, Scented, Deodorized
510(k) Number K864498
Device Name O.B.(TM) TAMPON
Applicant
PERSONAL PRODUCTS CO.
MILLTOWN,  NJ  08850
Applicant Contact A. J HUETTEMAN
Correspondent
PERSONAL PRODUCTS CO.
MILLTOWN,  NJ  08850
Correspondent Contact A. J HUETTEMAN
Regulation Number884.5460
Classification Product Code
HIL  
Date Received11/14/1986
Decision Date 01/27/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-