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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, phacofragmentation
510(k) Number K031404
Device Name DIGNITY OPHTHALMIC SURGICAL SYSTEM
Applicant
PHACOR INC., A SANTEN COMPANY
775 FIERO LN.
SAN LUIS OBISPO,  CA  93401
Applicant Contact JEFF B PAUL
Correspondent
PHACOR INC., A SANTEN COMPANY
775 FIERO LN.
SAN LUIS OBISPO,  CA  93401
Correspondent Contact JEFF B PAUL
Regulation Number886.4670
Classification Product Code
HQC  
Date Received05/05/2003
Decision Date 05/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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