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 Stylet, Tracheal Tube
510(k) Number K905133
Device Name STYLET TRACHAEL TUBE
Applicant
Medical Devices, Inc.
952 S. Zephyr Ct.
Lakewood,  CO  80226
Applicant Contact DAVID CHENOWETH
Correspondent
Medical Devices, Inc.
952 S. Zephyr Ct.
Lakewood,  CO  80226
Correspondent Contact DAVID CHENOWETH
Regulation Number868.5790
Classification Product Code
BSR  
Date Received11/15/1990
Decision Date 04/22/1991
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
-
-