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FDA 510(k) Application Details - K983076
Device Classification Name
Protector, Transducer, Dialysis
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510(K) Number
K983076
Device Name
Protector, Transducer, Dialysis
Applicant
MEDISYSTEMS CORP.
1900 K STREET, N.W.
WASHINGTON, DC 20006 US
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Contact
LARRY R PILOT
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Regulation Number
876.5820
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Classification Product Code
FIB
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More FDA Info for this Product Code
Date Received
09/02/1998
Decision Date
11/25/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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