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 Pad, Menstrual, Unscented
510(k) Number K003843
Device Name ENVIVE MINIFORMS
Applicant
PROCTER & GAMBLE CO.
6110 CENTER HILL AVE.
CINCINNATI,  OH  45224
Applicant Contact KATHLEEN C BLIEZNER
Correspondent
PROCTER & GAMBLE CO.
6110 CENTER HILL AVE.
CINCINNATI,  OH  45224
Correspondent Contact KATHLEEN C BLIEZNER
Regulation Number884.5435
Classification Product Code
HHD  
Date Received12/12/2000
Decision Date 02/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-