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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 NumberS002
Date Received05/14/2003
Decision Date06/09/2003
Product Code MWD 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ALTERNATE TEST METHOD FOR EVALUATION OF THE RADIOFREQUENCY OUTPUT OF THE RCS-300 CONSOLE DURING FINAL DEVICE TESTING.
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