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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accelerator, linear, medical
510(k) Number K945321
Device Name WELLHOFER WP700 V. 3.2
Applicant
MEDICAL PHYSICS INSTRUMENTATION, INC.
3080 STAGE POST DR., SUITE 109
BARTLETT,  TN  38133
Applicant Contact JOHN R BAIN
Correspondent
MEDICAL PHYSICS INSTRUMENTATION, INC.
3080 STAGE POST DR., SUITE 109
BARTLETT,  TN  38133
Correspondent Contact JOHN R BAIN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/01/1994
Decision Date 07/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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