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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 8-179: ASTM F754-08, standard specification for implantable polytetrafluoroethylene (ptfe) sheet, tube, and rod shapes fabricated from granular molding powders. (Materials)

Date of Standard: 2008. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Sutures, Facial Implants, Surgical Mesh
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Controls
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard with the following exceptions:

Paragraph 6 is not recognized.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Implant, Malar   LZK
§872.3930 Barrier, Synthetic, Intraoral Class 2 NPK
§878.3300 Mesh, Surgical, Polymeric Class 2 FTL
§878.3550 Prosthesis, Chin, Internal Class 2 FWP
§878.3590 Prosthesis, Ear, Internal Class 2 FZD
§878.3680 Prosthesis, Nose, Internal Class 2 FZE
§878.5010 Suture, Nonabsorbable, Synthetic, Polypropylene Class 2 GAW
§878.5010 Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride) Class 2 MXW
FDA Technical Contacts:
 Hany Demian (Materials)
  FDA/CDRH/ODE
  9200 Corporate Blvd., HFZ-410
  Rockville MD 20850
  240/276-3676
  email: hany.demian@fda.hhs.gov
 Michael J. Ryan (Dental)
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1615
  Silver Spring MD 20993
  301/796-6283
  email: michael.ryan@fda.hhs.gov
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