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 Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K954302
Device Name VYGON PREMI-CATH - LONG TERM CATHETER
Applicant
Vygon Corp.
304 Verona Ave.
Elizabeth,  NJ  07208
Applicant Contact HARRY A SCHLAKMAN
Correspondent
Vygon Corp.
304 Verona Ave.
Elizabeth,  NJ  07208
Correspondent Contact HARRY A SCHLAKMAN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received09/13/1995
Decision Date 06/17/1996
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
Recalls CDRH Recalls
-
-