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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 K161415
Device Name SteriTite Containers System & MediTray Products
Applicant
CASE MEDICAL, INC.
19 EMPIRE BLVD.
SOUTH HACKENSACK,  NJ  07606
Applicant Contact TANIA LUPU
Correspondent
CASE MEDICAL, INC.
19 EMPIRE BLVD.
SOUTH HACKENSACK,  NJ  07606
Correspondent Contact TANIA LUPU
Regulation Number880.6850
Classification Product Code
FRG  
Date Received05/23/2016
Decision Date 02/10/2017
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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