ENSEAL TISSUE SEALING DEVICE


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K072493
Device Name ENSEAL TISSUE SEALING DEVICE
Applicant
SURGRX INC
101 saginaw drive
redwood city, 
CA 
94063

Applicant Contact linda oleson
Correspondent
SURGRX INC
101 saginaw drive
redwood city, 
CA 
94063

Correspodent Contact linda oleson
Regulation Number 878.4400
Classification Product Code
GEI  
Subsequent Product Code
HGI  
Date Received 09/05/2007
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