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 drill, surgical, ent (electric or pneumatic) including handpiece
510(k) Number K781418
Device Name XOMED TRANSSPHENOIDAL HANDPIECE
Applicant
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Correspondent
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Regulation Number874.4250
Classification Product Code
ERL  
Date Received08/16/1978
Decision Date 08/31/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-