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 Prosthesis, Tracheal, Expandable
510(k) Number K001257
Device Name INTRACOIL STENT
Applicant
INTRATHERAPEUTICS, INC.
651 CAMPUS DR.
ST. PAUL,  MN  55112
Applicant Contact MARIA E BRITTLE
Correspondent
INTRATHERAPEUTICS, INC.
651 CAMPUS DR.
ST. PAUL,  MN  55112
Correspondent Contact MARIA E BRITTLE
Regulation Number878.3720
Classification Product Code
JCT  
Date Received04/19/2000
Decision Date 05/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
-
-