FDA 510(k) Application Details - K945659

Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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510(K) Number K945659
Device Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant XOMED-TREACE, INC.
6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE, FL US
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Regulation Number 874.4250

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Classification Product Code ERL
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Date Received 11/17/1994
Decision Date 01/09/1995
Decision SE - Substantially Equivalent
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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