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 Splint, Intranasal Septal
510(k) Number K153686
Device Name SPIWay Endonasal Access Guide
Applicant
Spiway, LLC
1120 Calle Cordillera, #102
San Clemente,  CA  92673
Applicant Contact EUGENE CHEN
Correspondent
Spiway, LLC
1120 Calle Cordillera, #102
San Clemente,  CA  92673
Correspondent Contact MARY LOU MOONEY
Regulation Number874.4780
Classification Product Code
LYA  
Date Received12/23/2015
Decision Date 01/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-