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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wrap, sterilization
510(k) Number K112904
Device Name STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS
Applicant
CASE MEDICAL, INC.
19 Empire Blvd
S Hackensack,  NJ  07606
Applicant Contact TANIA LUPU
Correspondent
CASE MEDICAL, INC.
19 Empire Blvd
S Hackensack,  NJ  07606
Correspondent Contact TANIA LUPU
Regulation Number880.6850
Classification Product Code
FRG  
Date Received10/04/2011
Decision Date 01/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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