FDA 510(k) Application Details - K954747

Device Classification Name Gown, Isolation, Surgical

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510(K) Number K954747
Device Name Gown, Isolation, 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 FYC
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Date Received 10/16/1995
Decision Date 03/06/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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