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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 K233002
Device Name BEED 2,5, BEED 3,8
Applicant
Excelsior Resources LLC
3011 NE 44th St.
Ft. Lauderdale,  FL  33308
Applicant Contact Christopher P Weber
Correspondent
Medlogics International LLC
12245 NW 48th Drive
Coral Springs,  FL  33076
Correspondent Contact Andrea Dwyer Steiner
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/22/2023
Decision Date 03/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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