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FDA 510(k) Application Details - K052075
Device Classification Name
Syringe, Piston
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510(K) Number
K052075
Device Name
Syringe, Piston
Applicant
AVANCA MEDICAL DEVICES, INC.
801 UNIVERSITY BLVD. SE
SUITE 307
ALBUQUERQUE, NM 87106 US
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Contact
FRANK FERGUSON
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Regulation Number
880.5860
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Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
08/01/2005
Decision Date
11/09/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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