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FDA 510(k) Application Details - K010787
Device Classification Name
Pacemaker Lead Adaptor
More FDA Info for this Device
510(K) Number
K010787
Device Name
Pacemaker Lead Adaptor
Applicant
Oscor Inc.
3816 DeSoto Blvd.
Palm Harbor, FL 34683 US
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Contact
MILA DOSKOCIL
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Regulation Number
870.3620
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Classification Product Code
DTD
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More FDA Info for this Product Code
Date Received
03/15/2001
Decision Date
05/22/2001
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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