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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 K990475
Device Name TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
Applicant
Kps & Assoc., Inc.
851 E. Northcrest Dr.
Salt Lake City,  UT  84103
Applicant Contact KRISHNA P SINHA
Correspondent
Kps & Assoc., Inc.
851 E. Northcrest Dr.
Salt Lake City,  UT  84103
Correspondent Contact KRISHNA P SINHA
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received02/16/1999
Decision Date 11/18/1999
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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