• 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 K812618
Device Name ASSURE NATURAL FIT 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 Received09/15/1981
Decision Date 10/02/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-