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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.
 
DeviceEASY EYES (TM)
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantEaton Medical Corp.
2288 Dunn Ave.
Memphis, TN 38114
PMA NumberP830009
Supplement NumberS008
Date Received10/21/1987
Decision Date03/23/1988
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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