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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 K090068
Device Name STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS
Applicant
CASE MEDICAL, INC.
65 RAILROAD AVE.
RIDGEFIELD,  NJ  07657 -0402
Applicant Contact TANIA LUPU
Correspondent
CASE MEDICAL, INC.
65 RAILROAD AVE.
RIDGEFIELD,  NJ  07657 -0402
Correspondent Contact TANIA LUPU
Regulation Number880.6850
Classification Product Code
FRG  
Date Received01/09/2009
Decision Date 02/24/2010
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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