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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCRYOMAX(TM)
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nameseparator, automated, blood cell and plasma, therapeutic
Applicant
STRATO MEDICAL CORP.
pfizer hospital products group
123 brimbal ave
beverly, MA 01915
PMA NumberP820002
Date Received01/05/1982
Decision Date01/31/1983
Product Code
LKN[ Registered Establishments with LKN ]
Docket Number 83M-0039
Notice Date 02/18/1983
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 
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