FDA 510(k) Application Details - K141785

Device Classification Name System, Ablation, Microwave And Accessories

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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
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Regulation Number 878.4400

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Classification Product Code NEY
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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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