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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 K915471
Device Name CRYOBAG
Applicant
Janus Biomedical, Inc.
2525 Hartford Rd.
Austin,  TX  78703
Applicant Contact RICHARD MARTIN
Correspondent
Janus Biomedical, Inc.
2525 Hartford Rd.
Austin,  TX  78703
Correspondent Contact RICHARD MARTIN
Classification Product Code
LPZ  
Date Received12/06/1991
Decision Date 03/02/1994
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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