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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Radionuclide
510(k) Number K960892
Device Name THE COBALT SCALPEL
Applicant
Nova Therapeutic System
2004 Le Droit Dr.
South Pasadena,  CA  91030
Applicant Contact JOSEPH S SHEPHERD
Correspondent
Nova Therapeutic System
2004 Le Droit Dr.
South Pasadena,  CA  91030
Correspondent Contact JOSEPH S SHEPHERD
Regulation Number892.5750
Classification Product Code
IWB  
Date Received03/05/1996
Decision Date 06/03/1996
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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