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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K930213
Device Name MODEL ASYM-100
Applicant
Nucletron Mfg. Corp.
David P. Armstrong
Box 786
Urbana,  VA  23175
Applicant Contact DPA CONSULTING
Correspondent
Nucletron Mfg. Corp.
David P. Armstrong
Box 786
Urbana,  VA  23175
Correspondent Contact DPA CONSULTING
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received01/15/1993
Decision Date 09/07/1993
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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