FDA 510(k) Application Details - K993907

Device Classification Name Pump, Infusion, Gallstone Dissolution

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510(K) Number K993907
Device Name Pump, Infusion, Gallstone Dissolution
Applicant AGILENT TECHNOLOGIES, INC.
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
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Contact DAVE OSBORN
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Regulation Number 880.5725

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Classification Product Code MHD
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Date Received 11/17/1999
Decision Date 12/06/1999
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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