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 bur, ear, nose and throat
510(k) Number K974232
Device Name ESSENTIAL SHAVER SYSTEM
Applicant
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact DEBORAH A ARTHUR
Correspondent
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact DEBORAH A ARTHUR
Regulation Number874.4140
Classification Product Code
EQJ  
Subsequent Product Code
ERL  
Date Received11/12/1997
Decision Date 01/12/1998
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
-
-