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FDA 510(k) Application Details - K041038
Device Classification Name
Container, I.V.
More FDA Info for this Device
510(K) Number
K041038
Device Name
Container, I.V.
Applicant
CHURCHILL MEDICAL SYSTEMS, INC.
87 VENTURE DR.
ENTERPRISE PARK
DOVER, NH 03820 US
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Contact
KEITH PALUCH
Other 510(k) Applications for this Contact
Regulation Number
880.5025
More FDA Info for this Regulation Number
Classification Product Code
KPE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/22/2004
Decision Date
12/21/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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