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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, cryosurgical, accessories
510(k) Number K113021
Device Name TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT
Original Applicant
CSA MEDICAL, INC.
1447 york rd ste 610
lutherville,  MD  21093
Original Contact colleen kistler
Regulation Number878.4350
Classification Product Code
GEH  
Date Received10/11/2011
Decision Date 02/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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