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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
510(k) Number K113475
Device Name ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
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
OCL  
Date Received11/22/2011
Decision Date 03/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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