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 K905735
Device Name GENNY DENNY IV SHIELD
Applicant
TADCO, INC.
1140 RANDOLPH RD.
FARMINGTON,  NM  87401
Applicant Contact THOMAS A DENNY
Correspondent
TADCO, INC.
1140 RANDOLPH RD.
FARMINGTON,  NM  87401
Correspondent Contact THOMAS A DENNY
Regulation Number880.5210
Classification Product Code
KMK  
Date Received12/24/1990
Decision Date 01/18/1991
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
-
-