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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 K234147
Device Name ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)
Applicant
Microline Surgical, Inc.
50 Dunham Rd., Suite 1500
Beverly,  MA  01915
Applicant Contact Scott Marchand Davis
Correspondent
Microline Surgical, Inc.
50 Dunham Rd., Suite 1500
Beverly,  MA  01915
Correspondent Contact Scott Marchand Davis
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/29/2023
Decision Date 04/23/2024
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
Predetermined Change
Control Plan Authorized		 No
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