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 Mesh, Surgical
510(k) Number K070738
Device Name SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
Applicant
Cook Biotech, Inc.
1425 Innovation Pl.
West Lafayette,  IN  47906
Applicant Contact MARY A FADERAN
Correspondent
Cook Biotech, Inc.
1425 Innovation Pl.
West Lafayette,  IN  47906
Correspondent Contact MARY A FADERAN
Regulation Number878.3300
Classification Product Code
FTM  
Date Received03/16/2007
Decision Date 04/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-