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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.
 
DeviceTHE SOFT LENS THERMAL DISINFECTING UNIT
Generic NameSterilizer, soft-lens, thermal, ac-powered
Regulation Number886.5928
ApplicantAbbott Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana, CA 92705
PMA NumberP820082
Supplement NumberS002
Date Received06/25/1987
Decision Date07/31/1987
Product Code HRD 
Advisory Committee Ophthalmic
Supplement Type 30-Day Supplement
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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