FDA 510(k) Application Details - K854332

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

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510(K) Number K854332
Device Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant MICRO-AIRE SURGICAL INSTRUMENTS, INC.
505 FOURTH ST.
SAN FERNANDO, CA US
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Contact GERALD BROOKS
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Regulation Number 874.4250

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Classification Product Code ERL
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Date Received 10/28/1985
Decision Date 01/21/1986
Decision SE - Substantially Equivalent
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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