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 Tubing, Fluid Delivery
510(k) Number K910906
Device Name CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS
Applicant
Tri-State Hospital Supply Corp.
301 Catrell Dr.
P.O. Box 170
Howell,  MI  48843
Applicant Contact GEORGE J PLUTA
Correspondent
Tri-State Hospital Supply Corp.
301 Catrell Dr.
P.O. Box 170
Howell,  MI  48843
Correspondent Contact GEORGE J PLUTA
Regulation Number880.5440
Classification Product Code
FPK  
Date Received03/05/1991
Decision Date 04/01/1991
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
-
-