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 K884884
Device Name OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL
Applicant
Porex Technologies Corp. OF Georgia
500 Bohannon Rd.
Fairburn,  GA  30213
Applicant Contact HOWARD A MERCER,PHD
Correspondent
Porex Technologies Corp. OF Georgia
500 Bohannon Rd.
Fairburn,  GA  30213
Correspondent Contact HOWARD A MERCER,PHD
Regulation Number874.3495
Classification Product Code
ETA  
Date Received11/22/1988
Decision Date 06/16/1989
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
Predetermined Change
Control Plan Authorized		 No
-
-