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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameJSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR
Classification Namelens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantSZABOCSIK AND ASSOCIATES
PMA NumberP040029
Supplement NumberS001
Date Received08/29/2005
Decision Date10/14/2005
Product Code
NUU[ Registered Establishments with NUU ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a protocol of acceptable procedures to allow one or more independent finishing laboratories to manufacture and distribute finished rgp contact lenses for overnight orthokeratology made from lens blanks.
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