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 Pessary, Vaginal
510(k) Number K904026
Device Name INFLAT-O-BALL
Applicant
MILEX PRODUCTS, INC.
5915 NORTHWEST HIGHWAY
CHICAGO,  IL  60631
Applicant Contact GARY CHUVEN
Correspondent
MILEX PRODUCTS, INC.
5915 NORTHWEST HIGHWAY
CHICAGO,  IL  60631
Correspondent Contact GARY CHUVEN
Regulation Number884.3575
Classification Product Code
HHW  
Date Received08/30/1990
Decision Date 10/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-