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, Percutaneous
510(k) Number K931403
Device Name SITERITE NEEDLE GUIDE (MODIFIED)
Applicant
Dymax Corp
604 Epsilon Dr.
Pittsburgh,  PA  15238
Applicant Contact IRENE SKOLNICK
Correspondent
Dymax Corp
604 Epsilon Dr.
Pittsburgh,  PA  15238
Correspondent Contact IRENE SKOLNICK
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/19/1993
Decision Date 07/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-