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FDA 510(k) Application Details - K032754
Device Classification Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
More FDA Info for this Device
510(K) Number
K032754
Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant
HORIZON MEDICAL PRODUCTS, INC.
1 HORIZON WAY
MANCHESTER, GA 31816 US
Other 510(k) Applications for this Company
Contact
SCOTT MOELLER
Other 510(k) Applications for this Contact
Regulation Number
880.5965
More FDA Info for this Regulation Number
Classification Product Code
LJT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/05/2003
Decision Date
09/12/2003
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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