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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 K945383
Device Name HIGH DOSE RATE AFTERLOADER
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 Received10/25/1994
Decision Date 02/15/1995
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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