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 Replacement, Ossicular Prosthesis, Total
510(k) Number K981088
Device Name MILLS COLUMELLA PROSTHESIS
Applicant
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON,  GB TA1 2LB
Applicant Contact MARGARET BLACKEMORE
Correspondent
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON,  GB TA1 2LB
Correspondent Contact MARGARET BLACKEMORE
Regulation Number874.3495
Classification Product Code
ETA  
Date Received03/25/1998
Decision Date 06/05/1998
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
-
-