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FDA 510(k) Application Details - K965222
Device Classification Name
Pump, Infusion, Elastomeric
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510(K) Number
K965222
Device Name
Pump, Infusion, Elastomeric
Applicant
MICROJECT, INC.
2203 WEST ALEXANDER ST.
SALT LAKE CITY, UT 84119 US
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Contact
LARRY RIGBY
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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
12/31/1996
Decision Date
06/19/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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