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FDA 510(k) Application Details - K990889
Device Classification Name
Pump, Infusion, Elastomeric
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510(K) Number
K990889
Device Name
Pump, Infusion, Elastomeric
Applicant
TANDEM MEDICAL, INC.
15910 BERNARDO CENTER DR.
SAN DIEGO, CA 92127 US
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Contact
ALBERT MISAJON
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Regulation Number
880.5725
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Classification Product Code
MEB
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More FDA Info for this Product Code
Date Received
03/17/1999
Decision Date
06/03/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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