FDA 510(k) Application Details - K980827

Device Classification Name Finger Cot

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510(K) Number K980827
Device Name Finger Cot
Applicant TUCKER & ASSOCIATES
198 AVE. DE LA D' EMERALD
SPARKS, NV 89434-9550 US
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Contact JANNA P TUCKER
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Regulation Number 880.6250

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Classification Product Code LZB
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Date Received 03/03/1998
Decision Date 05/04/1998
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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