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 Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K192305
Device Name Colibri Endoscopy System
Applicant
3nt Medical , Ltd.
22 Hamelacha St., Pob 11384
Rosh Ha'Ayin,  IL 4809169
Applicant Contact Ehud Bendory
Correspondent
Orly Maor
25a Sirkin St.
Kfar Saba,  IL 4442156
Correspondent Contact Orly Maor
Regulation Number874.4760
Classification Product Code
EOB  
Date Received08/23/2019
Decision Date 02/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-