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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 10-88
ASTM D790-10 Standard Test Methods for Flexure Properties of Unreinforced Plastics and Electrical Insulating Materials
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.5916 Lens, Contact (Other Material) - Daily Class 2 HQD
§886.5916 Lens, Contact (Rigid Gas Permeable), Extended Wear Class 3 MWL
Relevant FDA Guidance and/or Supportive Publications*
Premarket Notification (510k) Guidance Document for Daily Wear Contact Lenses, Issued May 1994
FDA Technical Contact
 Joseph C. Hutter
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6499
  joseph.hutter@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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