THE ABLATION SYSTEM


Device Classification Name

coagulator, laparoscopic, unipolar (and accessories)

510(k) Number K121858
Device Name THE ABLATION SYSTEM
Applicant
HALT MEDICAL INC.
131 sand creek road, suite b
brentwood, 
CA 
94513

Applicant Contact clarisa tate
Correspondent
HALT MEDICAL INC.
131 sand creek road, suite b
brentwood, 
CA 
94513

Correspodent Contact clarisa tate
Regulation Number 884.4160
Classification Product Code
HFG  
Date Received 06/26/2012
Decision Date 11/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Clinical Trials NCT00874029
Reviewed by Third Party No

Combination Product

No