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FDA 510(k) Application Details - K082782
Device Classification Name
Vessel Guard Or Cover
More FDA Info for this Device
510(K) Number
K082782
Device Name
Vessel Guard Or Cover
Applicant
REPLICATION MEDICAL INC
901 KING STREET
SUITE 200
ALEXANDRIA, VA 22314 US
Other 510(k) Applications for this Company
Contact
MARCOS VELEZ-DURAN
Other 510(k) Applications for this Contact
Regulation Number
870.3470
More FDA Info for this Regulation Number
Classification Product Code
OMR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/22/2008
Decision Date
04/02/2009
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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