FDA 510(k) Application Details - K102048

Device Classification Name Clamp, Vascular

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510(K) Number K102048
Device Name Clamp, Vascular
Applicant GEOMED MEDIZIN- TECHNIK GMBH & CO. KG
UNTERER WINKEL 3
WUMLINGEN 78532 DE
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Contact HARALD JUNG
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 07/21/2010
Decision Date 11/09/2010
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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