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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 K962131
Device Name STORZ D4600 AIR EXCHANGE LINE PACK
Applicant
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122 -6694
Applicant Contact AUDREY SWEARINGEN
Correspondent
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122 -6694
Correspondent Contact AUDREY SWEARINGEN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/03/1996
Decision Date 08/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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