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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 K081503
Device Name AED MONOPOLAR LAP ACCESSORIES
Applicant
National Advanced Endoscopy Devices, Inc.
22134 Sherman Way
Canoga Park,  CA  91303
Applicant Contact GAYLE M BUTLER
Correspondent
National Advanced Endoscopy Devices, Inc.
22134 Sherman Way
Canoga Park,  CA  91303
Correspondent Contact GAYLE M BUTLER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/29/2008
Decision Date 09/25/2008
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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