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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 K171804
Device Name Zap-X Radiosurgery System
Applicant
Zap Surgical Systems
590 Taylor Way
Suite A
San Carlos,  CA  94070
Applicant Contact Radhika Mohan Bodduluri
Correspondent
Experien Group, LLC
224 Airport Pkwy., Suite 250
San Jose,  CA  95110
Correspondent Contact Darlene Crockett-Billig
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/19/2017
Decision Date 09/21/2017
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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