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 K964042
Device Name EXTRESAFE PHLEBOTOMY
Applicant
Specialized Health Products, Inc.
9721 S. Altamont Dr.
Sandy,  UT  84092
Applicant Contact WILLIAM E MCKAY
Correspondent
Specialized Health Products, Inc.
9721 S. Altamont Dr.
Sandy,  UT  84092
Correspondent Contact WILLIAM E MCKAY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/08/1996
Decision Date 06/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-