FDA 510(k) Application Details - K011172

Device Classification Name Staple, Absorbable

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510(K) Number K011172
Device Name Staple, Absorbable
Applicant ARTHREX, INC.
2885 SOUTH HORSESHOE DR.
NAPLES, FL 34104 US
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Contact VERNON BROWN
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Regulation Number 888.3030

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Classification Product Code MNU
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Date Received 04/17/2001
Decision Date 06/19/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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