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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K892425
Device Name STP COMPLETE MODULE SET
Applicant
Leibinger & Fischer , Ltd.
4500 Trammell Crow Center
2001 Ross Ave.
Dallas,  TX  75201
Applicant Contact & MCKENZIE
Correspondent
Leibinger & Fischer , Ltd.
Im Hausgrun 29
Emmendingen,  DE 79312
Correspondent Contact Saschka Busch
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/10/1989
Decision Date 03/23/1990
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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