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 button, nasal septal
510(k) Number K013696
Device Name SILMED NASAL SEPTAL BUTTON
Applicant
SILMED, INC.
3987 LAKEVIEW TRAIL
LEESBURG,,  IN  46538
Applicant Contact RAMA GUNDLAPALLI
Correspondent
SILMED, INC.
3987 LAKEVIEW TRAIL
LEESBURG,,  IN  46538
Correspondent Contact RAMA GUNDLAPALLI
Classification Product Code
LFB  
Date Received11/07/2001
Decision Date 11/28/2001
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-