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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 K100224
Device Name ESTECH COBRA BIPOLSR II
Applicant
Endoscopic Technologies, Inc. D/B/A Estech
2603 Camino Ramon
Suite 100
San Ramon,  CA  94583
Applicant Contact TAMER IBRAHIM
Correspondent
Endoscopic Technologies, Inc. D/B/A Estech
2603 Camino Ramon
Suite 100
San Ramon,  CA  94583
Correspondent Contact TAMER IBRAHIM
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/26/2010
Decision Date 04/07/2010
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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