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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K890294
Device Name INTER-PAL C-19 AND INTER-PAL C-38
Applicant
Enrad Corp.
4613 Romberg Pl.
Woodland Hills,  CA  91364
Applicant Contact BRUCE R SATHER
Correspondent
Enrad Corp.
4613 Romberg Pl.
Woodland Hills,  CA  91364
Correspondent Contact BRUCE R SATHER
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received01/19/1989
Decision Date 02/01/1990
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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