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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 K050671
Device Name ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
Applicant
Surgrx, Inc.
380 Portage Ave.
Palo Alto,  CA  94306
Applicant Contact LINDA OLESON
Correspondent
Surgrx, Inc.
380 Portage Ave.
Palo Alto,  CA  94306
Correspondent Contact LINDA OLESON
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HGI  
Date Received03/15/2005
Decision Date 04/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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