FDA 510(k) Application Details - K052387

Device Classification Name Finger Cot

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510(K) Number K052387
Device Name Finger Cot
Applicant ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES, FL 34108-1945 US
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Contact ANN WATERHOUSE
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Regulation Number 880.6250

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Classification Product Code LZB
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Date Received 08/31/2005
Decision Date 11/29/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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