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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.
 
DeviceHYPERION LTK SYSTEM
Generic NameLaser, ophthalmic
Regulation Number886.4390
ApplicantSUNRISE TECHNOLOGIES, INC.
3400 W. WARREN AVE.
FREMONT, CA 94538
PMA NumberP990078
Supplement NumberS005
Date Received08/20/2001
Decision Date05/08/2002
Product Code HQF 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT A-PLUS/C-MAC, FREMONT, CALIFORNIA.
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