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FDA 510(k) Application Details - K960676
Device Classification Name
Pulse-Generator, Pacemaker, External
More FDA Info for this Device
510(K) Number
K960676
Device Name
Pulse-Generator, Pacemaker, External
Applicant
ZOLL MEDICAL CORP.
32 SECOND AVE.
BURLINGTON, MA 01803 US
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Contact
BLAKE A CERULLO
Other 510(k) Applications for this Contact
Regulation Number
870.3600
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Classification Product Code
DTE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/20/1996
Decision Date
06/05/1996
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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