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 monitor, pressure, intrauterine
510(k) Number K974730
Device Name SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)
Applicant
GRAPHIC CONTROLS CORP.
189 VAN RENSSELAER ST.
P.O. BOX 1274
BUFFALO,  NY  14240
Applicant Contact KATHLEEN H SELOVER
Correspondent
GRAPHIC CONTROLS CORP.
189 VAN RENSSELAER ST.
P.O. BOX 1274
BUFFALO,  NY  14240
Correspondent Contact KATHLEEN H SELOVER
Regulation Number884.2700
Classification Product Code
KXO  
Date Received12/18/1997
Decision Date 07/14/1998
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
-
-