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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.
 
DeviceSOFT MATE(R) DW (HEFILICON A) CONTACT LENS
Generic NameSterilizer, soft-lens, thermal, ac-powered
Regulation Number886.5928
ApplicantWesley Jessen Corp.
333 E. Howard Ave.
Des Plaines, IL 60018
PMA NumberN17367
Supplement NumberS012
Date Received12/20/1983
Decision Date04/16/1984
Product Code HRD 
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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