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 Polymer, Ear, Nose And Throat, Synthetic, Absorbable
510(k) Number K070715
Device Name NASOPORE EAR
Applicant
Polyganics B.V.,
L.J. Zielstraweg 1
Groningen,  NL 9713-GX
Applicant Contact JAN NIEUWENHUIS
Correspondent
Polyganics B.V.,
L.J. Zielstraweg 1
Groningen,  NL 9713-GX
Correspondent Contact JAN NIEUWENHUIS
Regulation Number874.3620
Classification Product Code
NHB  
Date Received03/14/2007
Decision Date 05/07/2007
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
Recalls CDRH Recalls
-
-