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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K831329
Device Name PMT VAXIOM STEREOTACTIC SYS #FX001
Applicant
PROGRESS MANKIND TECHNOLOGY
BOX 464
HOPKINS,  MN  55343
Applicant Contact Alfred A Iversen
Correspondent
PROGRESS MANKIND TECHNOLOGY
BOX 464
HOPKINS,  MN  55343
Correspondent Contact Alfred A Iversen
Regulation Number882.4560
Classification Product Code
HAW  
Date Received04/25/1983
Decision Date 06/15/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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