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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 K041599
Device Name COBRA ADHERE SURGICAL SYSTEM
Applicant
Estech, Inc.
1193 Sherman St.
Alameda,  CA  94501
Applicant Contact CRAIG COOMBS
Correspondent
Estech, Inc.
1193 Sherman St.
Alameda,  CA  94501
Correspondent Contact CRAIG COOMBS
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
OCL  
Date Received06/14/2004
Decision Date 07/27/2004
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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