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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 K230432
Device Name Single Use Bipolar Forceps
Applicant
Hg Innovations, Ltd.
5 Elder Court, Lions Dr.
Shadsworth Business Park, Blackburn
Lancashire,  GB BB1 2EQ
Applicant Contact Dr.M Umran Rafiq
Correspondent
Medical Device Academy, Inc.
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Wondwossen Tekolla
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/17/2023
Decision Date 05/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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