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 Needle, Hypodermic, Single Lumen
510(k) Number K102994
Device Name K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR
Applicant
Kawasumi Laboratories, Inc.
4723 Oak Fair Blvd.
Tampa,  FL  33610
Applicant Contact JACK PAVLO
Correspondent
Kawasumi Laboratories, Inc.
4723 Oak Fair Blvd.
Tampa,  FL  33610
Correspondent Contact JACK PAVLO
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/08/2010
Decision Date 11/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-