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FDA 510(k) Application Details - K141785
Device Classification Name
System, Ablation, Microwave And Accessories
More FDA Info for this Device
510(K) Number
K141785
Device Name
System, Ablation, Microwave And Accessories
Applicant
BSD MEDICAL CORP.
2188 WEST 2200 SOUTH
SALT LAKE CITY, UT 84119 US
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Contact
DIXIE TOOLSON SELLS
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
NEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/02/2014
Decision Date
03/31/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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