FDA 510(k) Application Details - K011238

Device Classification Name Pump, Infusion, Analytical Sampling

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510(K) Number K011238
Device Name Pump, Infusion, Analytical Sampling
Applicant METRACOR TECHNOLOGIES, INC.
11425 SORRENTO VALLEY RD.
SAN DIEGO, CA 92121 US
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Contact GEORGE F MCHUGH
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Regulation Number 880.5725

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Classification Product Code LZF
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Date Received 04/23/2001
Decision Date 01/08/2002
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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