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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 K130027
Device Name DISPOSABLE NEUTRAL ELECTRODE GP202
Applicant
Cathay Manufacturing Corp.
# 328, Xishe Rd., Maogang Town, Songjiang Area
Shanghai,  CN 201607
Applicant Contact ZHANG HUI
Correspondent
Cathay Manufacturing Corp.
# 328, Xishe Rd., Maogang Town, Songjiang Area
Shanghai,  CN 201607
Correspondent Contact ZHANG HUI
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/03/2013
Decision Date 08/22/2013
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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