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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 K210526
Device Name Medline Cautery Tip Cleaner
Applicant
Medline Industries, Inc.
Three Lakes Dr.
Nortfield,  IL  60093
Applicant Contact Matt Clausen
Correspondent
Medline Industries, Inc.
Three Lakes Dr.
Nortfield,  IL  60093
Correspondent Contact Matt Clausen
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/23/2021
Decision Date 03/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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