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FDA 510(k) Application Details - K954258
Device Classification Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
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510(K) Number
K954258
Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant
GERARD MEDICAL ENTERPRISES, INC.
90 WORCESTER RD.
UNIT 2, BOX 6
CHARLTON, MA 01507 US
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Contact
RICHARD CAYER
Other 510(k) Applications for this Contact
Regulation Number
880.5965
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Classification Product Code
LJT
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More FDA Info for this Product Code
Date Received
09/05/1995
Decision Date
05/24/1996
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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