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FDA 510(k) Application Details - K011943
Device Classification Name
Cement Obturator
More FDA Info for this Device
510(K) Number
K011943
Device Name
Cement Obturator
Applicant
KENSEY NASH CORP.
55 EAST UWCHLAN AVE.
MARSH CREEK CORP. CENTER
EXTON, PA 19341-1247 US
Other 510(k) Applications for this Company
Contact
JULIE N BRODERICK
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
LZN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/21/2001
Decision Date
09/19/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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