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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 K963624
Device Name PHILIPS SLI SERIES LINEAR ACCELERATOR
Applicant
Philips Medical Systems, Inc.
710 Bridgeport Ave.
P.O. Box 860
Shelton,  CT  06484
Applicant Contact PETER ALTMAN
Correspondent
Philips Medical Systems, Inc.
710 Bridgeport Ave.
P.O. Box 860
Shelton,  CT  06484
Correspondent Contact PETER ALTMAN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/11/1996
Decision Date 12/06/1996
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
Recalls CDRH Recalls
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