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, tracheal (w/wo connector)
510(k) Number K953368
Device Name LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES
Applicant
KARL STORZ ENDOSKOP GMBH
600 CORPORATE POINTE
CULVER CITY,  CA  90230
Applicant Contact RENATE A MACLAREN
Correspondent
KARL STORZ ENDOSKOP GMBH
600 CORPORATE POINTE
CULVER CITY,  CA  90230
Correspondent Contact RENATE A MACLAREN
Regulation Number868.5730
Classification Product Code
BTR  
Date Received07/18/1995
Decision Date 09/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-