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FDA 510(k) Application Details - K961716
Device Classification Name
Catheter, Embolectomy
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510(K) Number
K961716
Device Name
Catheter, Embolectomy
Applicant
IDEAS FOR MEDICINE, INC.
12167 49TH ST. NORTH
P.O. BOX 17327
CLEARWATER, FL 34622 US
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Contact
ELIZABETH M PAUL
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Regulation Number
870.5150
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Classification Product Code
DXE
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More FDA Info for this Product Code
Date Received
05/02/1996
Decision Date
09/19/1996
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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