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, Tracheostomy (W/Wo Connector)
510(k) Number K874450
Device Name SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT
Applicant
Surgitech C/O Collier, Shannon, Rill & Scott
1055 Thomas Jefferson St. NW
Washington,  DC  20007
Applicant Contact RICHARD S SILVERMAN
Correspondent
Surgitech C/O Collier, Shannon, Rill & Scott
1055 Thomas Jefferson St. NW
Washington,  DC  20007
Correspondent Contact RICHARD S SILVERMAN
Regulation Number868.5800
Classification Product Code
BTO  
Date Received10/29/1987
Decision Date 02/29/1988
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
-
-