• 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, Short-Term Less Than 30 Days
510(k) Number K070705
Device Name MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
Applicant
VYGON CORP.
2495 GENERAL ARMISTEAD AVE
NORRISTOWN,  PA  19403
Applicant Contact COURTNEY SMITH
Correspondent
VYGON CORP.
2495 GENERAL ARMISTEAD AVE
NORRISTOWN,  PA  19403
Correspondent Contact Jay F W
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/14/2007
Decision Date 11/30/2007
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
Recalls CDRH Recalls
-
-