DOMAIN SURGICAL SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K110439
Device Name DOMAIN SURGICAL SYSTEM
Applicant
DOMAIN SURGICAL, INC.
1370 south 2100 east
salt lake sity, 
UT 
84108

Applicant Contact curtis jensen
Correspondent
DOMAIN SURGICAL, INC.
1370 south 2100 east
salt lake sity, 
UT 
84108

Correspodent Contact curtis jensen
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 02/15/2011
Decision Date 07/18/2011
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