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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 NumberS006
Date Received12/04/2003
Decision Date01/15/2004
Product Code MWD 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE SUB-ASSEMBLY OF THE RCS-300 CONSOLE COMPONENT AT STELLARTECH RESEARCH CORP., SUNNYVALE, CALIFORNIA.
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