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 K032636
Device Name PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
Applicant
PLAYTEX PRODUCTS, INC.
75 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Applicant Contact KAREN A COSTA
Correspondent
PLAYTEX PRODUCTS, INC.
75 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Correspondent Contact KAREN A COSTA
Regulation Number884.5470
Classification Product Code
HEB  
Date Received08/27/2003
Decision Date 11/14/2003
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
-
-