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FDA 510(k) Application Details - K132184
Device Classification Name
Coagulator, Laparoscopic, Unipolar (And Accessories)
More FDA Info for this Device
510(K) Number
K132184
Device Name
Coagulator, Laparoscopic, Unipolar (And Accessories)
Applicant
HALT MEDICAL INC
131 SAND CREEK RD STE., B
BRENTWOOD, CA 94513 US
Other 510(k) Applications for this Company
Contact
CLARISA TATE
Other 510(k) Applications for this Contact
Regulation Number
884.4160
More FDA Info for this Regulation Number
Classification Product Code
HFG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/15/2013
Decision Date
04/28/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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