FDA 510(k) Application Details - K000704

Device Classification Name Catheter, Irrigation

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510(K) Number K000704
Device Name Catheter, Irrigation
Applicant DMC MEDICAL LTD.
511 CATALINA RD.
FULLERTON, CA 92835 US
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Contact CHARMAINE HENDERSON
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Regulation Number 878.4200

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Classification Product Code GBX
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Date Received 03/02/2000
Decision Date 05/19/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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