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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K910956
Device Name COMPUSCAN LT BIOMETRIC RULER AND IOL CALCULATOR
Applicant
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact MICHAEL T TAGGART
Correspondent
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact MICHAEL T TAGGART
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/06/1991
Decision Date 09/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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