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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 K152400
Device Name General & Plastic Surgery Instruments
Applicant
Sontec Instruments, Inc.
7248 S. Tucson Way
Centennial,  CO  80112
Applicant Contact Stefan M. Scanlan
Correspondent
Hart Consulting, LLC
2964 Redhaven Way
Littleton,  CO  80126
Correspondent Contact Charles M. (Mike) Hart
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/25/2015
Decision Date 01/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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