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 Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K032119
Device Name PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS
Applicant
Paragon Medical, Inc.
7822 Ladue Glen
Fort Wayne,  IN  46804
Applicant Contact DAVID C FURR
Correspondent
Paragon Medical, Inc.
7822 Ladue Glen
Fort Wayne,  IN  46804
Correspondent Contact DAVID C FURR
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/09/2003
Decision Date 10/29/2003
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
Predetermined Change
Control Plan Authorized		 No
-
-