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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 K252714
Device Name C-Lant Port
Applicant
Vigor Medical Technologies , Ltd.
13 Yohanan Hasandlar
Haifa,  IL
Applicant Contact Irina Kavounovski
Correspondent
ProMedoss, Inc.
6026 Beech Cove Ln
Charlotte,  NC  28269
Correspondent Contact Bosmat Friedman
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/27/2025
Decision Date 02/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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