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 spatula, cervical, cytological
510(k) Number K072381
Device Name SOFTPAP CERVICAL CELL COLLECTOR
Applicant
CYTOCORE, INC.
414 NORTH ORLEAN
SUITE 502
CHICAGO,  IL  60610
Applicant Contact RICHARD DOMANIK
Correspondent
CYTOCORE, INC.
414 NORTH ORLEAN
SUITE 502
CHICAGO,  IL  60610
Correspondent Contact RICHARD DOMANIK
Regulation Number884.4530
Classification Product Code
HHT  
Date Received08/24/2007
Decision Date 01/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-