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 Instrument, Ent Manual Surgical
510(k) Number K153341
Device Name Relieva Scout Multi-Sinus Dilation System
Applicant
Acclarent, Inc.
1525-B O'Brien Dr.
Rmenlo Park,  CA  94025
Applicant Contact JAMES PATRICK GARVEY
Correspondent
Acclarent, Inc.
1525-B O'Brien Dr.
Rmenlo Park,  CA  94025
Correspondent Contact JAMES PATRICK GARVEY
Regulation Number874.4420
Classification Product Code
LRC  
Date Received11/19/2015
Decision Date 02/12/2016
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
Predetermined Change
Control Plan Authorized		 No
-
-