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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 K080558
Device Name STERITITE CONTAINER SYSTEM & 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 Received02/28/2008
Decision Date 12/05/2008
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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