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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 K031285
Device Name MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD
Applicant
Megadyne Medical Products, Inc.
4545 Creek Road
Cincinnati,  OH  45242
Applicant Contact Correne Ramy
Correspondent
Megadyne Medical Products, Inc
4545 Creek Road
Cincinnati,  OH  45242
Correspondent Contact Correne Ramy
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/23/2003
Decision Date 05/19/2003
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
Recalls CDRH Recalls
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