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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K232903
Device Name Legend X Platform
Applicant
Pollogen, Ltd.
6 Kaufman St.
Tel Aviv,  IL 68012
Applicant Contact Karen Smith
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
NGX  
Date Received09/18/2023
Decision Date 10/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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