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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 K951142
Device Name PULSE KLYSTRON AMPLIFIER (L-5822-00)
Applicant
Litton Systems, Inc.
960 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact FREDICK G ESMOND
Correspondent
Litton Systems, Inc.
960 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact FREDICK G ESMOND
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/13/1995
Decision Date 06/16/1995
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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