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, Tympanostomy
510(k) Number K103595
Device Name ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
Applicant
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK,  CA  94025
Applicant Contact GURVINDER SINGH NANDA
Correspondent
ACCLARENT, INC.
1525-B O'BRIEN DR.
MENLO PARK,  CA  94025
Correspondent Contact GURVINDER SINGH NANDA
Regulation Number874.3880
Classification Product Code
ETD  
Date Received12/08/2010
Decision Date 04/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT01202578
Reviewed by Third Party No
Combination Product No
-
-