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 K033053
Device Name ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
Applicant
Alveolus, Inc.
9013 Perimeter Woods Suite A
Charlotte,  NC  28216
Applicant Contact Howard Schrayer
Correspondent
Alveolus, Inc.
9013 Perimeter Woods Suite A
Charlotte,  NC  28216
Correspondent Contact Howard Schrayer
Regulation Number878.3720
Classification Product Code
JCT  
Date Received09/29/2003
Decision Date 02/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-