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FDA 510(k) Application Details - K953044
Device Classification Name
Permanent Pacemaker Electrode
More FDA Info for this Device
510(K) Number
K953044
Device Name
Permanent Pacemaker Electrode
Applicant
BIOTRONIK, INC.
6024 JEAN ROAD
LAKE OSWEGO, OR 97035 US
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Contact
JOSEPH J SCHOWEBEL
Other 510(k) Applications for this Contact
Regulation Number
870.3680
More FDA Info for this Regulation Number
Classification Product Code
DTB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/1995
Decision Date
09/27/1996
Decision
PT - Substantially Equivalent - Subject to Tracking & PMS
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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