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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name folders and injectors, intraocular lens (iol)
510(k) Number K970727
Device Name MPORT FOLDABLE LENS PLACEMENT SYSTEM
Applicant
CHIRON VISION CORP.
555 W. ARROW HWY.
CLAREMONT,  CA  91711
Applicant Contact JUDY F GORDON
Correspondent
CHIRON VISION CORP.
555 W. ARROW HWY.
CLAREMONT,  CA  91711
Correspondent Contact JUDY F GORDON
Regulation Number886.4300
Classification Product Code
MSS  
Date Received02/28/1997
Decision Date 12/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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