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 K953096
Device Name ESSENTIAL SHAVER SYSTEM
Applicant
SMITH & NEPHEW RICHARDS, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact DEBORAH A ARTHUR
Correspondent
SMITH & NEPHEW RICHARDS, INC.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact DEBORAH A ARTHUR
Regulation Number874.4140
Classification Product Code
EQJ  
Subsequent Product Code
ERL  
Date Received07/03/1995
Decision Date 07/28/1995
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
-
-