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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 K103310
Device Name CRYONIZE TM
Applicant
3JT ENTERPRISES LLC
2000 N. RACINE AVE
SUITE 3100
CHICAGO,  IL  60614
Applicant Contact ANTHONY GOLDBOSS
Correspondent
3JT ENTERPRISES LLC
2000 N. RACINE AVE
SUITE 3100
CHICAGO,  IL  60614
Correspondent Contact ANTHONY GOLDBOSS
Regulation Number878.4350
Classification Product Code
GEH  
Date Received11/10/2010
Decision Date 02/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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