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FDA 510(k) Application Details - K992958
Device Classification Name
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
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510(K) Number
K992958
Device Name
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Applicant
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON, NH 03051 US
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Contact
KAREN HALL
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Regulation Number
870.3450
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Classification Product Code
DYF
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More FDA Info for this Product Code
Date Received
09/02/1999
Decision Date
10/01/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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