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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVIEWPOINT CK SYSTEM
Generic NameElectrosurgical, radio frequency, refractive correction
ApplicantREFRACTEC, INC.
5 JENNER, SUITE 150
IRVINE, CA 92618
PMA NumberP010018
Supplement NumberS008
Date Received09/08/2005
Decision Date09/30/2005
Product Code MWD 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMPLEMENTATION OF A CONTROLLED ADHESIVE APPLICATION PROCESS TO MORE ACCURATELY CONTROL THE AMOUNT OF ADHESIVE APPLIED.
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