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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K193459
Device Name Panther Stereotactic
Applicant
Prowess, Inc.
1844 Clayton Rd.
Concord,  CA  94520
Applicant Contact Rachel Scarano
Correspondent
Prowess, Inc.
1844 Clayton Rd.
Concord,  CA  94520
Correspondent Contact Rachel Scarano
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
IWB  
Date Received12/16/2019
Decision Date 04/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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