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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K171344
Device Name Xenocor Xenoscope Laparoscopic System
Applicant
Xenocor, Inc.
630 Komas Dr.
Suite 200
Salt Lake City,  UT  84108
Applicant Contact Spencer Walker
Correspondent
Xenocor, Inc.
630 Komas Dr.
Suite 200
Salt Lake City,  UT  84108
Correspondent Contact Spencer Walker
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HET  
Date Received05/08/2017
Decision Date 06/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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