FDA 510(k) Application Details - K992539

Device Classification Name Finger Cot

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510(K) Number K992539
Device Name Finger Cot
Applicant DIGIT-PRO
10555 WEST LITTLE YORK RD.
HOUSTON, TX 77041 US
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Contact KEVIN SORRELS
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Regulation Number 880.6250

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Classification Product Code LZB
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Date Received 07/30/1999
Decision Date 02/18/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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