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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 K213127
Device Name ReNew Disposable Scissor Tips
Applicant
Microline Surgical, Inc.
50 Dunham Road, Suite 1500
Beverly,  MA  01915
Applicant Contact Scott Marchand Davis
Correspondent
Microline Surgical, Inc.
50 Dunham Road, Suite 1500
Beverly,  MA  01915
Correspondent Contact Scott Marchand Davis
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/27/2021
Decision Date 03/02/2022
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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