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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 K961310
Device Name STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
Applicant
STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Applicant Contact MICHAEL SOUTHWORTH
Correspondent
STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Correspondent Contact MICHAEL SOUTHWORTH
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Code
HQE  
Date Received04/04/1996
Decision Date 06/27/1996
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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