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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 K833642
Device Name PHAKO SYSTEMS VIA 2000
Applicant
PHAROSYSTEMS, INC.
4221 Richmond Rd., N.W.
walker,  MI  49534
Correspondent
PHAROSYSTEMS, INC.
4221 Richmond Rd., N.W.
walker,  MI  49534
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/17/1983
Decision Date 03/05/1984
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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