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 Confocal Optical Imaging
510(k) Number K160416
Device Name CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
Applicant
MAUNA KEA TECHNOLOGIES
9, RUE D'ENGHIEN
PARIS,  FR 75010
Applicant Contact VERONIQUE DENTAN
Correspondent
DANIEL & DANIEL CONSULTING
340 JONES LANE
GARDENVILLE,  NV  89460
Correspondent Contact Michael A. Daniel
Regulation Number876.1500
Classification Product Code
OWN  
Date Received02/16/2016
Decision Date 05/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-