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FDA 510(k) Application Details - K021581
Device Classification Name
More FDA Info for this Device
510(K) Number
K021581
Device Name
HEMOSORB
Applicant
ON SITE GAS SYSTEMS, INC.
35 BUDNEY RD.
NEWINGTON, CT 06111 US
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Contact
FRANCIS X HURSEY
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Regulation Number
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Classification Product Code
QSY
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More FDA Info for this Product Code
Date Received
05/14/2002
Decision Date
07/12/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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