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FDA 510(k) Application Details - K003443
Device Classification Name
System, Evacuator, Fluid
More FDA Info for this Device
510(K) Number
K003443
Device Name
System, Evacuator, Fluid
Applicant
APPLIED MEDICAL
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
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Contact
ANIL BHALANI
Other 510(k) Applications for this Contact
Regulation Number
876.4370
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Classification Product Code
FHF
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More FDA Info for this Product Code
Date Received
11/06/2000
Decision Date
02/01/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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