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FDA 510(k) Application Details - K970204
Device Classification Name
Pacemaker Lead Adaptor
More FDA Info for this Device
510(K) Number
K970204
Device Name
Pacemaker Lead Adaptor
Applicant
BIOTRONIK, INC.
6024 SW JEAN RD. B4
LAKE OSWEGO, OR 97035-3594 US
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Contact
Joseph J Schwoebel
Other 510(k) Applications for this Contact
Regulation Number
870.3620
More FDA Info for this Regulation Number
Classification Product Code
DTD
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More FDA Info for this Product Code
Date Received
01/21/1997
Decision Date
04/29/1997
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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