• 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 Microdebrider, Ent, High Speed, Single Use, Reprocessed
510(k) Number K142022
Device Name MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
Applicant
MEDLINE RENEWAL
2747 SW 6th St
REDMOND,  OR  97756
Applicant Contact RICHARD D WYNKOOP
Correspondent
MEDLINE RENEWAL
2747 SW 6th St
REDMOND,  OR  97756
Correspondent Contact RICHARD D WYNKOOP
Regulation Number874.4140
Classification Product Code
NLY  
Date Received07/25/2014
Decision Date 12/19/2014
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
-
-