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
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Regulation Number 882.4175

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Classification Product Code HCI
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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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