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 K935842
Device Name RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE
Applicant
Rusch, Inc.
2450 Meadowbrook Pkwy.
Duluth,  GA  30096
Applicant Contact KARENANN J BROZOWSKI
Correspondent
Rusch, Inc.
2450 Meadowbrook Pkwy.
Duluth,  GA  30096
Correspondent Contact KARENANN J BROZOWSKI
Regulation Number868.5730
Classification Product Code
BTR  
Date Received12/07/1993
Decision Date 05/23/1995
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
Recalls CDRH Recalls
-
-