ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K081129
Device Name ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL
Applicant
SURGRX, INC.
101 saginaw dr.
redwood city, 
CA 
94063

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

Correspodent Contact linda oleson
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 04/21/2008
Decision Date 07/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No