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FDA 510(k) Application Details - K981032
Device Classification Name
More FDA Info for this Device
510(K) Number
K981032
Device Name
PIV SYSTEM
Applicant
MEDICAL SOLUTIONS, INC.
P.O BOX 4343
CROFTON, MD 21114 US
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Contact
E J SMITH
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Regulation Number
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Classification Product Code
LDQ
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More FDA Info for this Product Code
Date Received
03/19/1998
Decision Date
09/02/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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