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 K897012
Device Name SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS
Applicant
PLAYTEX FAMILY PRODUCTS, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS,  NJ  07653
Applicant Contact BUTENSKY, PHD
Correspondent
PLAYTEX FAMILY PRODUCTS, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS,  NJ  07653
Correspondent Contact BUTENSKY, PHD
Regulation Number884.5460
Classification Product Code
HIL  
Date Received12/20/1989
Decision Date 12/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-