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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Frozen Donor Tissue Storage
510(k) Number K861761
Device Name ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact JOHN BRDA
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact JOHN BRDA
Classification Product Code
LPZ  
Date Received05/06/1986
Decision Date 08/28/1986
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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