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 And Tube Cuff
510(k) Number K970811
Device Name DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN
Applicant
Pneumocare, Inc.
23991 Ironhead Ln.
Laguna Niguel,  CA  92677
Applicant Contact JOSEPH H BALES
Correspondent
Pneumocare, Inc.
23991 Ironhead Ln.
Laguna Niguel,  CA  92677
Correspondent Contact JOSEPH H BALES
Regulation Number868.5800
Classification Product Code
JOH  
Date Received03/05/1997
Decision Date 11/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-