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 K872112
Device Name XOMED PLATINUM WIRE TEFLON PISTION
Applicant
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216 -0980
Applicant Contact GORDON PETERS
Correspondent
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE,  FL  32216 -0980
Correspondent Contact GORDON PETERS
Regulation Number874.3450
Classification Product Code
ETB  
Date Received06/01/1987
Decision Date 07/02/1987
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
-
-