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 Speculum, Ent
510(k) Number K791123
Device Name EAR AND NOSE SPECULA
Applicant
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Correspondent
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Regulation Number878.1800
Classification Product Code
EPY  
Date Received06/15/1979
Decision Date 07/10/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-