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FDA 510(k) Application Details - K020276
Device Classification Name
Marker, Radiographic, Implantable
More FDA Info for this Device
510(K) Number
K020276
Device Name
Marker, Radiographic, Implantable
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
Other 510(k) Applications for this Company
Contact
GEORGE C ABERNATHY
Other 510(k) Applications for this Contact
Regulation Number
878.4300
More FDA Info for this Regulation Number
Classification Product Code
NEU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/28/2002
Decision Date
04/12/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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