FDA 510(k) Application Details - K051488

Device Classification Name Suture, Knot, Mechanical

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510(K) Number K051488
Device Name Suture, Knot, Mechanical
Applicant MEDICINELODGE, INC.
180 SOUTH 600 WEST
LOGAN, UT 84321 US
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Contact M. MRY SINNOTT
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Regulation Number 878.5000

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Classification Product Code NVH
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Date Received 06/06/2005
Decision Date 07/27/2005
Decision SESE - SUBST EQUIV
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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