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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.
 
DeviceCRYSTALENS SALINE SPRAY
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantStericon, Inc.
19742 Macarthur Blvd.
Suite 235
Irvine, CA 92715
PMA NumberP850065
Supplement NumberS013
Date Received06/22/1990
Decision Date10/24/1990
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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