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 K972815
Device Name PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
Applicant
Grace Medical, Inc.
7715 Hwy. 70, Suite 109
Bartlett,  TN  38133
Applicant Contact ANTHONY D PRESCOTT
Correspondent
Grace Medical, Inc.
7715 Hwy. 70, Suite 109
Bartlett,  TN  38133
Correspondent Contact ANTHONY D PRESCOTT
Regulation Number874.3450
Classification Product Code
ETB  
Subsequent Product Code
ETA  
Date Received07/28/1997
Decision Date 10/08/1997
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
Predetermined Change
Control Plan Authorized		 No
-
-