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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)
Applicant
CIBA VISION CARE
P.O. BOX 105069
ATLANTA,  GA  30348
Applicant Contact PAUL G STAPLETON
Correspondent
CIBA VISION CARE
P.O. BOX 105069
ATLANTA,  GA  30348
Correspondent 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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