FDA 510(k) Application Details - K973587

Device Classification Name Tube, Ear Suction

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510(K) Number K973587
Device Name Tube, Ear Suction
Applicant EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET TA1 2LB GB
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Contact MARGARET BLACKMORE
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Regulation Number 874.4420

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Classification Product Code JZF
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Date Received 09/22/1997
Decision Date 01/23/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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