FDA 510(k) Application Details - K980221

Device Classification Name Splint, Intranasal Septal

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510(K) Number K980221
Device Name Splint, Intranasal Septal
Applicant SILIMED, LLC.
P.O BOX 4341
CROFTON, MD 21114 US
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Contact E.J. Smith
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Regulation Number 874.4780

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Classification Product Code LYA
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Date Received 01/22/1998
Decision Date 04/02/1998
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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