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FDA 510(k) Application Details - K965030
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K965030
Device Name
Syringe, Piston
Applicant
VASCULAR LOGICS, INC.
5862 BOLSA AVE.
SUITE 108
HUNTINGTON BEACH, CA 92649 US
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Contact
JAMES K BRANNON
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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
12/17/1996
Decision Date
03/04/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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