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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 K962335
Device Name MLC FIT
Applicant
Impac Medical Systems, Inc.
215 Castro St.
Mountain View,  CA  94041 -1203
Applicant Contact JOSEPH K JACHINOWSKI
Correspondent
Impac Medical Systems, Inc.
215 Castro St.
Mountain View,  CA  94041 -1203
Correspondent Contact JOSEPH K JACHINOWSKI
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/17/1996
Decision Date 02/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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