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 Device, Intravascular Catheter Securement
510(k) Number K912942
Device Name IV HOUSE
Applicant
Progressive Iv'S, Inc.
7400 Foxmont Dr.
Hazelwood,  MO  63042
Applicant Contact BETT M ROZIER
Correspondent
Progressive Iv'S, Inc.
7400 Foxmont Dr.
Hazelwood,  MO  63042
Correspondent Contact BETT M ROZIER
Regulation Number880.5210
Classification Product Code
KMK  
Date Received07/03/1991
Decision Date 09/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-