FDA 510(k) Application Details - K990432

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K990432
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant SUTURES LTD.
VAUXHALL IND. ESTATE
RUABON, WREXHAM LL14 6HA GB
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Contact ELEANOR JONES
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Regulation Number 878.4493

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Classification Product Code GAM
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Date Received 02/11/1999
Decision Date 05/27/1999
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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