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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 K022978
Device Name STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS
Applicant
Case Medical, Inc.
65 Railroad Ave.
Ridgefield,  NJ  07657 -0402
Applicant Contact MARCIA A FRIEZE
Correspondent
Case Medical, Inc.
65 Railroad Ave.
Ridgefield,  NJ  07657 -0402
Correspondent Contact Tania Lupu
Regulation Number880.6850
Classification Product Code
FRG  
Date Received09/06/2002
Decision Date 05/09/2003
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
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