FDA 510(k) Application Details - K993424

Device Classification Name Clip, Implantable

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510(K) Number K993424
Device Name Clip, Implantable
Applicant Y-CLIP ASSOCIATES
116 DEFENSE HIGHWAY
ANNAPOLIS, MD 21401 US
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Contact GEORGE YU
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 10/12/1999
Decision Date 12/23/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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