FDA 510(k) Application Details - K002915

Device Classification Name Clamp, Vascular

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510(K) Number K002915
Device Name Clamp, Vascular
Applicant APPLIED MEDICAL
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
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Contact ANIL BHALANI
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 09/18/2000
Decision Date 01/08/2001
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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