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FDA 510(k) Application Details - K973132
Device Classification Name
Clamp, Vascular
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510(K) Number
K973132
Device Name
Clamp, Vascular
Applicant
TZ MEDICAL, INC.
15858 S.W. UPPER BOONES FERRY
RD.
LAKE OSWEGO, OR 97035 US
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Contact
BYRON ZAHLER
Other 510(k) Applications for this Contact
Regulation Number
870.4450
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Classification Product Code
DXC
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More FDA Info for this Product Code
Date Received
08/21/1997
Decision Date
01/12/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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