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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K942778
Device Name MODEL VPW2877F8, MAMMO 5 POWER SUPPLY
Applicant
Varian Assoc., Inc.
45 River Dr.
Georgetown,  CA L7G 2J4
Applicant Contact ANTHONY B BAILEY
Correspondent
Varian Assoc., Inc.
45 River Dr.
Georgetown,  CA L7G 2J4
Correspondent Contact ANTHONY B BAILEY
Regulation Number892.1700
Classification Product Code
IZO  
Date Received06/13/1994
Decision Date 07/29/1994
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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