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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 K980480
Device Name SYNTEC VITMAN
Applicant
Syntec, Inc.
743 Spirit 40 Park Dr.
Suite 112
Chesterfield,  MO  63005
Applicant Contact JAMES TAYLOR
Correspondent
Syntec, Inc.
743 Spirit 40 Park Dr.
Suite 112
Chesterfield,  MO  63005
Correspondent Contact JAMES TAYLOR
Regulation Number886.4670
Classification Product Code
HQC  
Date Received02/03/1998
Decision Date 05/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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