FDA 510(k) Application Details - K984345

Device Classification Name Applicator, Ent Drug

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510(K) Number K984345
Device Name Applicator, Ent Drug
Applicant ENVIS, INC.
25 HERTIAGE DR.
ASHEVILLE, NC 28806 US
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Contact STEVE WOODY
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Regulation Number 874.5220

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Classification Product Code LRD
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Date Received 12/04/1998
Decision Date 03/19/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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