FDA 510(k) Application Details - K982365

Device Classification Name Clamp, Vascular

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510(K) Number K982365
Device Name Clamp, Vascular
Applicant GEISTER MEDIZINTECHNIK GMBH
FOEHRENSTR. 2
TUTTLINGEN D-78532 DE
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Contact DAGMAR S MASER
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 07/07/1998
Decision Date 04/08/1999
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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