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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 K072493
Device Name ENSEAL TISSUE SEALING DEVICE
Applicant
Surgrx, Inc.
101 Saginaw Dr.
Redwood City,  CA  94063
Applicant Contact LINDA OLESON
Correspondent
Surgrx, Inc.
101 Saginaw Dr.
Redwood City,  CA  94063
Correspondent Contact LINDA OLESON
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HGI  
Date Received09/05/2007
Decision Date 09/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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