FDA 510(k) Application Details - K954455

Device Classification Name Cap, Surgical

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510(K) Number K954455
Device Name Cap, Surgical
Applicant AMERASIA CORP.
4121 TIGRIS WAY
RIVERSIDE, CA 92503 US
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Contact DAVID SONG
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Regulation Number 878.4040

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Classification Product Code FYF
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Date Received 09/25/1995
Decision Date 01/23/1996
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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