FDA 510(k) Application Details - K993184

Device Classification Name Pump, Infusion, Insulin

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510(K) Number K993184
Device Name Pump, Infusion, Insulin
Applicant ANIMAS CORP.
590 E. LANCASTER AVE.
FRAZER, PA 19355 US
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Contact MONICA FERRANTE
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Regulation Number 880.5725

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Classification Product Code LZG
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Date Received 09/23/1999
Decision Date 02/10/2000
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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