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FDA 510(k) Application Details - K982379
Device Classification Name
Applier, Aneurysm Clip
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510(K) Number
K982379
Device Name
Applier, Aneurysm Clip
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM, MA 02767 US
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Contact
JANET G JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
882.4175
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Classification Product Code
HCI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/08/1998
Decision Date
12/18/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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