FDA 510(k) Application Details - K972175

Device Classification Name Catheter, Continuous Flush

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510(K) Number K972175
Device Name Catheter, Continuous Flush
Applicant LOCALMED, INC.
1820 EMBARCADERO RD.
PALO ALTO, CA 94303 US
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Contact EDWIN L EE
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 06/09/1997
Decision Date 08/28/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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