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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K981672
Device Name RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR
Applicant
Radiotherapeutics Corp.
2685 Marine Way, Suite 1408
Mountain View,  CA  94043
Applicant Contact COLIN J NICHOLS
Correspondent
Radiotherapeutics Corp.
2685 Marine Way, Suite 1408
Mountain View,  CA  94043
Correspondent Contact COLIN J NICHOLS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/12/1998
Decision Date 07/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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