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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Guide, Intraocular
510(k) Number K951292
Device Name PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
Applicant
Chiron Vision Corp.
Indust Park Hato Rte 183
San Lorenzo,  PR  00754
Applicant Contact JUDY F GORDON
Correspondent
Chiron Vision Corp.
Indust Park Hato Rte 183
San Lorenzo,  PR  00754
Correspondent Contact JUDY F GORDON
Regulation Number886.4300
Classification Product Code
KYB  
Date Received03/22/1995
Decision Date 06/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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