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 Connector, Airway (Extension)
510(k) Number K951345
Device Name DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING
Applicant
Catheter Research, Inc.
6131 W. 80th St.
Indianapolis,  IN  46278
Applicant Contact JOHN A STEEN
Correspondent
Catheter Research, Inc.
6131 W. 80th St.
Indianapolis,  IN  46278
Correspondent Contact JOHN A STEEN
Regulation Number868.5810
Classification Product Code
BZA  
Date Received03/23/1995
Decision Date 04/14/1995
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
-
-