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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 K002932
Device Name PHACOGARD
Applicant
Syntec, Inc.
733 Mansion Rd.
Winfield,  MO  63389
Applicant Contact JIM EASLEY
Correspondent
Syntec, Inc.
733 Mansion Rd.
Winfield,  MO  63389
Correspondent Contact JIM EASLEY
Regulation Number886.4670
Classification Product Code
HQC  
Date Received09/20/2000
Decision Date 01/04/2001
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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