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 Introducer, Syringe Needle
510(k) Number K951384
Device Name V-CATH PERCUTANEOUS INTRODUCER KIT
Applicant
Hdc Corp.
2109-O'Toole Ave.
San Jose,  CA  95131
Applicant Contact GRETCHEN MARCHESANI
Correspondent
Hdc Corp.
2109-O'Toole Ave.
San Jose,  CA  95131
Correspondent Contact GRETCHEN MARCHESANI
Regulation Number880.6920
Classification Product Code
KZH  
Date Received03/27/1995
Decision Date 06/23/1995
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
-
-