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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Beam Limiting, X-Ray, Therapeutic
510(k) Number K844180
Device Name THE MCP-70-SE SYSTEM
Applicant
Ellis Pharmaceutical Consulting, Inc.
913 State Rd.
Princeton,  NJ  08540
Applicant Contact LEVI ELLIS
Correspondent
Ellis Pharmaceutical Consulting, Inc.
913 State Rd.
Princeton,  NJ  08540
Correspondent Contact LEVI ELLIS
Regulation Number892.5900
Classification Product Code
KQA  
Date Received10/26/1984
Decision Date 02/01/1985
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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