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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 K964947
Device Name PHOTON RADIOSURGERY SYSTEM (PRS)
Applicant
Photoelectron Corporation
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact JAMES R VEALE
Correspondent
Photoelectron Corporation
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact JAMES R VEALE
Regulation Number892.5900
Classification Product Code
JAD  
Date Received12/10/1996
Decision Date 06/20/1997
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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