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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone marrow collection/transfusion kit
510(k) Number K913306
Device Name BONE-TEMNO/STERNUM-TEMNO
Applicant
PROACT, LTD.
CALDER SQUARE BOX 11029
STATE COLLEGE,  PA  16805
Applicant Contact JOSEPH M LOONEY
Correspondent
PROACT, LTD.
CALDER SQUARE BOX 11029
STATE COLLEGE,  PA  16805
Correspondent Contact JOSEPH M LOONEY
Classification Product Code
LWE  
Date Received07/25/1991
Decision Date 11/01/1991
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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