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, Chin, Internal
510(k) Number K933367
Device Name GORE-TEX FACIAL IMPLANT
Applicant
W. L. Gore & Associates, Inc.
1505 N. Fourth St.
P.O. Box 3000
Flagstaff,  AZ  86003
Applicant Contact LARRY J KOVACH
Correspondent
W. L. Gore & Associates, Inc.
1505 N. Fourth St.
P.O. Box 3000
Flagstaff,  AZ  86003
Correspondent Contact LARRY J KOVACH
Regulation Number878.3550
Classification Product Code
FWP  
Subsequent Product Code
LZK  
Date Received07/09/1993
Decision Date 07/28/1994
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-