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 Catheters, Suction, Tracheobronchial
510(k) Number K955645
Device Name CATH-GUIDE
Applicant
Hudson Respiratory Care, Inc.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Applicant Contact PAUL E DRYDEN
Correspondent
Hudson Respiratory Care, Inc.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Correspondent Contact PAUL E DRYDEN
Regulation Number868.6810
Classification Product Code
BSY  
Date Received12/12/1995
Decision Date 03/12/1996
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
-
-