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 Prosthesis, Partial Ossicular Replacement
510(k) Number K993234
Device Name MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
Applicant
MICROMEDICS, INC.
1285 CORPORATE CENTER DR.,
#150
EAGAN,  MN  55121
Applicant Contact CHARLES GROTE
Correspondent
MICROMEDICS, INC.
1285 CORPORATE CENTER DR.,
#150
EAGAN,  MN  55121
Correspondent Contact CHARLES GROTE
Regulation Number874.3450
Classification Product Code
ETB  
Date Received09/27/1999
Decision Date 11/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-