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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nameseparator, automated, blood cell and plasma, therapeutic
920 winter street
waltham, MA 02451
PMA NumberP850020
Supplement NumberS005
Date Received03/09/1993
Decision Date04/29/1993
Product Code
LKN[ Registered Establishments with LKN ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No