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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accessories, soft lens products
510(k) Number K863346
Device Name PROFESSIONAL DISINFECTION SYSTEM (PDS)
Original Applicant
CIBA VISION CARE
p.o. box 105069
atlanta,  GA  30348
Original Contact paul g stapleton
Regulation Number886.5928
Classification Product Code
LPN  
Date Received08/29/1986
Decision Date 02/27/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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