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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.
 
DeviceBOSTON LENS(R) CLEANER
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantPolymer Technology Corp.
100 Research Dr.
Wilmington, MA 01887
PMA NumberP820069
Supplement NumberS013
Date Received07/22/1994
Decision Date08/15/1994
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day 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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