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FDA 510(k) Application Details - K021439
Device Classification Name
Pump, Infusion, Insulin
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510(K) Number
K021439
Device Name
Pump, Infusion, Insulin
Applicant
ANIMAS CORP.
590 E. LANCASTER AVE.
FRAZER, PA 19355 US
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Contact
MICHAEL J ANDREWS
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
LZG
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More FDA Info for this Product Code
Date Received
05/06/2002
Decision Date
05/29/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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