• 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 bronchoscope (flexible or rigid)
510(k) Number K142909
Device Name Flexible 19G EBUS Needle
Applicant
SPIRATION, INC.
6675 185TH AVENUE NE
REDMOND,  WA  98052
Applicant Contact Cyndy J Adams
Correspondent
SPIRATION, INC.
6675 185TH AVENUE NE
REDMOND,  WA  98052
Correspondent Contact Cyndy J Adams
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received10/06/2014
Decision Date 04/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-