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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K091350
Device Name ESTECH HAWKEYE INTRODUCER SYSTEMS
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 Number876.1500
Classification Product Code
GCJ  
Date Received05/07/2009
Decision Date 09/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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