• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Recognition List Number: 025 FR Publication Date: 10/04/2010 

Part B: Supplementary Information

Recognition Number 6-110: ASTM F1441-03 (Reapproved 2009), standard specification for soft-tissue expander devices. (General Plastic Surgery/General Hospital)

Date of Standard: 2009. 
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 SURVEILLANCE AND BIOMETRICS (OSB)
(3)OFFICE OF COMPLIANCE (OC)
(4)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
Devices Affected:
Tissue Expanders
Processes Affected:
510(k), PMA, GMP, PDP, IDE, HDE, PreIDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Expander, Skin, Inflatable   LCJ
FDA Technical Contact:
 David Kraus
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G434
  Silver Spring MD 20993
  301/796-6970
  email: david.kraus@fda.hhs.gov
-
-