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 K843729
Device Name SHILEY DISPOS. CANNULA FENESTRATED LOW
Applicant
Shiley, Inc.
17600 Gillette Ave.
Irvine,  CA  92714
Applicant Contact KAREN SALINAS
Correspondent
Shiley, Inc.
17600 Gillette Ave.
Irvine,  CA  92714
Correspondent Contact KAREN SALINAS
Regulation Number868.5800
Classification Product Code
BTO  
Date Received09/24/1984
Decision Date 10/19/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-