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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 K020320
Device Name RADIOSYSTEM/NT, MODEL 80-13020
Applicant
Styker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact KELLI BITTERBURG
Correspondent
Styker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact KELLI BITTERBURG
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
KXK  
Date Received01/31/2002
Decision Date 08/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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