FDA 510(k) Application Details - K042288

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K042288
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
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 878.4493

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Classification Product Code GAM
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Date Received 08/24/2004
Decision Date 12/27/2004
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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