FDA 510(k) Application Details - K103310

Device Classification Name Unit, Cryosurgical, Accessories

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510(K) Number K103310
Device Name Unit, Cryosurgical, Accessories
Applicant 3JT ENTERPRISES LLC
2000 N. RACINE AVE
SUITE 3100
CHICAGO, IL 60614 US
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Contact ANTHONY GOLDBOSS
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Regulation Number 878.4350

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Classification Product Code GEH
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Date Received 11/10/2010
Decision Date 02/09/2011
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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