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 K173757
Device Name VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set
Applicant
Greiner Bio-One Na, Inc.
4238 Capital Dr.
Monroe,  NC  28110
Applicant Contact Manfred Abel
Correspondent
Greiner Bio-One Na, Inc.
4238 Capital Dr.
Monroe,  NC  28110
Correspondent Contact Manfred Abel
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
FPA  
Date Received12/11/2017
Decision Date 04/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-