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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 K853663
Device Name ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR
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 Received09/03/1985
Decision Date 04/09/1986
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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