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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K992577
Device Name PHOTON RADIOSURGERY SYSTEM (PRS)
Applicant
Photoelectron Corporation
5 Forbes Rd.
Lexington,  MA  02421
Applicant Contact PAUL A PELLETIER
Correspondent
Photoelectron Corporation
5 Forbes Rd.
Lexington,  MA  02421
Correspondent Contact PAUL A PELLETIER
Regulation Number892.5900
Classification Product Code
JAD  
Date Received08/02/1999
Decision Date 09/23/1999
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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