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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 K132184
Device Name ACESSA GUIDANCE HANDPIECE
Applicant
HALT MEDICAL INC
131 SAND CREEK RD STE., B
BRENTWOOD,  CA  94513
Applicant Contact CLARISA TATE
Correspondent
HALT MEDICAL INC
131 SAND CREEK RD STE., B
BRENTWOOD,  CA  94513
Correspondent Contact CLARISA TATE
Regulation Number884.4160
Classification Product Code
HFG  
Date Received07/15/2013
Decision Date 04/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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