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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 K193315
Device Name Xenocor Articulating Xenoscope Laparoscope
Applicant
Xenocor, Inc.
630 Komas Dr., Suite 200
Salt Lake City,  UT  84108
Applicant Contact Evan Kelso
Correspondent
University of Utah
10 N. 1900 E., Ehsl Rm, 22b
Salt Lake City,  UT  84112
Correspondent Contact Spencer Walker
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
GCQ   HET  
Date Received11/29/2019
Decision Date 01/27/2020
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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