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 Tube, Tracheostomy (W/Wo Connector)
510(k) Number K101721
Device Name WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
Applicant
Regulatory and Marketing Services, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
Regulatory and Marketing Services, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number868.5800
Classification Product Code
BTO  
Date Received06/18/2010
Decision Date 03/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-