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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 K946176
Device Name STORZ PHACOEMULSIFICATION NEEDLES
Applicant
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122 -6694
Applicant Contact MICHAEL H SOUTHWORTH
Correspondent
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122 -6694
Correspondent Contact MICHAEL H SOUTHWORTH
Regulation Number886.4670
Classification Product Code
HQC  
Date Received12/19/1994
Decision Date 02/14/1995
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
Recalls CDRH Recalls
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