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 K952677
Device Name MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
Applicant
Porex Surgical, Inc.
4715 Roosevelt Hwy.
College Park,  GA  30349 -2417
Applicant Contact HOWARD MERCER
Correspondent
Porex Surgical, Inc.
4715 Roosevelt Hwy.
College Park,  GA  30349 -2417
Correspondent Contact HOWARD MERCER
Regulation Number878.3550
Classification Product Code
FWP  
Date Received06/12/1995
Decision Date 08/21/1995
Decision Substantially Equivalent (SESE)
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
Recalls CDRH Recalls
-
-