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FDA 510(k) Application Details - K983744
Device Classification Name
Clip, Vascular
More FDA Info for this Device
510(K) Number
K983744
Device Name
Clip, Vascular
Applicant
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS, CA 92653 US
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Contact
HOWARD V ROWE
Other 510(k) Applications for this Contact
Regulation Number
870.3250
More FDA Info for this Regulation Number
Classification Product Code
DSS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/23/1998
Decision Date
01/21/1999
Decision
SESE - SUBST EQUIV
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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