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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 K924685
Device Name STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM
Applicant
Leibinger GmbH
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Leibinger GmbH
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/16/1992
Decision Date 09/16/1994
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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