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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 K233644
Device Name Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)
Applicant
Megadyne Medical Products, Inc.
4545 Creek Road
Cincinnati,  OH  45242
Applicant Contact Brian Godwin
Correspondent
Megadyne Medical Products, Inc.
4545 Creek Road
Cincinnati,  OH  45242
Correspondent Contact Brian Godwin
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/13/2023
Decision Date 07/12/2024
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
Recalls CDRH Recalls
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