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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator, Laparoscopic, Unipolar (And Accessories)
510(k) Number K121858
Device Name THE ABLATION SYSTEM
Applicant
Halt Medical, Inc.
131 Sand Creek Rd. Suite B
Brentwood,  CA  94513
Applicant Contact CLARISA TATE
Correspondent
Halt Medical, Inc.
131 Sand Creek Rd. Suite B
Brentwood,  CA  94513
Correspondent Contact CLARISA TATE
Regulation Number884.4160
Classification Product Code
HFG  
Date Received06/26/2012
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
Predetermined Change
Control Plan Authorized		 No
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