FDA 510(k) Application Details - K020393

Device Classification Name Drape, Surgical

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510(K) Number K020393
Device Name Drape, Surgical
Applicant MASTER & FRANK ENTERPRSES CO.LTD.
15F-1 NO 57 SEC 2
TUN HWA SOUTH RD
TAIPEI TW
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Contact FRANK WU
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 02/06/2002
Decision Date 05/03/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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