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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 K053326
Device Name ESTECH COBRA ELECTROSURGICAL UNIT & CABLE
Applicant
Endoscopic Technologies, Inc.
1193 Sherman St.
Alameda,  CA  94501
Applicant Contact CRAIG COOMBS
Correspondent
Endoscopic Technologies, Inc.
1193 Sherman St.
Alameda,  CA  94501
Correspondent Contact CRAIG COOMBS
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
OCL  
Date Received12/01/2005
Decision Date 01/06/2006
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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