FDA 510(k) Application Details - K042285

Device Classification Name Suture, Surgical, Absorbable, Polydioxanone

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510(K) Number K042285
Device Name Suture, Surgical, Absorbable, Polydioxanone
Applicant UNITED MEDICAL INDUSTRIES CO. LTD.
3RD INDUSTRIAL CITY
SANAYYA, OPPOSITE TO OBAIKAN
RIYADH, CENTRAL PROVINCE 11553 SA
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Contact MOHAMMED AZEEZ
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Regulation Number 878.4840

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Classification Product Code NEW
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Date Received 08/24/2004
Decision Date 12/10/2004
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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