FDA 510(k) Application Details - K923161

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyester

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510(K) Number K923161
Device Name Suture, Nonabsorbable, Synthetic, Polyester
Applicant MITEK SURGICAL PRODUCTS, INC.
57 PROVIDENCE HWY.
NORWOOD, MA US
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Contact ROBERT P ZOLETTI
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Regulation Number 878.5000

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Classification Product Code GAS
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Date Received 06/29/1992
Decision Date 12/30/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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