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510(k) Premarket Notification

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Device Classification Name arthroscope
510(k) NumberK001741
Device NameRADIONICS RF DISC CATHETER ELECTRODE SYSTEM
Applicant
RADIONICS, INC.
22 terry ave.
burlington,  MA  01803 251
Contactkristine canavan
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GEI  
Date Received06/08/2000
Decision Date 10/23/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee General & Plastic Surgery
Statement/Summary/Purged Status Summary/purged 510(k)
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
 
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