FDA 510(k) Application Details - K030788

Device Classification Name Dilator, Vessel, Surgical

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510(K) Number K030788
Device Name Dilator, Vessel, Surgical
Applicant GEISTER MEDIZINTECHNIK GMBH
AMSTEL 320-I
AMSTERDAM 1017 AP NL
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Contact DAGMAR MASER
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Regulation Number 870.4475

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Classification Product Code DWP
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Date Received 03/12/2003
Decision Date 07/12/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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