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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 K953570
Device Name PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP)
Applicant
Philips Medical Systems, Inc.
710 Bridgeport Ave.
Shelton,  CT  06484
Applicant Contact TIMOTHY CAPEHART
Correspondent
Philips Medical Systems, Inc.
710 Bridgeport Ave.
Shelton,  CT  06484
Correspondent Contact TIMOTHY CAPEHART
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/31/1995
Decision Date 10/25/1995
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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