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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Containment System, Laparoscopic Power Morcellation, With Instrument Port
510(k) Number K250212
Device Name LapBox Power Tissue Containment System
Applicant
Ark Surgical
13 Wadi El Haj
13 Wadi El Haj,  IL 1603611
Applicant Contact Stav Tori
Correspondent
ProMedoss, Inc.
6026 Beech Cove Ln
Charlotte,  NC  28269
Correspondent Contact Bosmat Friedman-Cox
Regulation Number884.4050
Classification Product Code
PMU  
Date Received01/24/2025
Decision Date 04/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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