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 K171917
Device Name Frova Intubating Introducer
Applicant
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47404
Applicant Contact Kotei Aoki
Correspondent
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47404
Correspondent Contact Kotei Aoki
Regulation Number868.5730
Classification Product Code
BTR  
Date Received06/27/2017
Decision Date 04/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-