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FDA 510(k) Application Details - K964384
Device Classification Name
Set, Administration, Intravascular
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510(K) Number
K964384
Device Name
Set, Administration, Intravascular
Applicant
PATIENT SOLUTIONS, INC.
13220 EVENING CREEK DR. SO.,
SUITE 114
SAN DIEGO, CA 92128 US
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Contact
TOM KANE
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
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More FDA Info for this Product Code
Date Received
11/04/1996
Decision Date
01/27/1997
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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