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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 K954467
Device Name CADPLAN BT
Applicant
Varian Assoc., Inc.
3045 Hanover St.
Palo Alto,  CA  94304
Applicant Contact CHARLES H WILL
Correspondent
Varian Assoc., Inc.
3045 Hanover St.
Palo Alto,  CA  94304
Correspondent Contact CHARLES H WILL
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received09/26/1995
Decision Date 03/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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