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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 K201435
Device Name Molecular Flow Simulations
Applicant
Therataxis, LLC
Johns Hopkins Eastern Bldg. Suite B305
1101 E. 33rd St.
Baltimore,  MD  21218
Applicant Contact Raghu Raghavan
Correspondent
Convergent Clinical,Inc.
6648 Surf Crest St.
Carlsbad,  CA  92011
Correspondent Contact Al Memmolo
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
QRI  
Date Received06/01/2020
Decision Date 12/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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