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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 Recognition 01/30/2014 
FR Recognition Number 10-87
Standard
ASTM D882-12
Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§886.5925 Lens, Contact, (Disposable) Class 2 MVN
§886.5925 Lenses, Soft Contact, Daily Wear Class 2 LPL
§886.5925 Lenses, Soft Contact, Extended Wear Class 3 LPM
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/OMPT/CDRH/ODE/DOED/ICIB/
  301-796-6499
  joseph.hutter@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Ophthalmic
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