FDA 510(k) Application Details - K981631

Device Classification Name Clip, Implantable

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510(K) Number K981631
Device Name Clip, Implantable
Applicant INFLUENCE, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004 US
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Contact JONATHAN S KAHAN
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 05/07/1998
Decision Date 07/28/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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