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FDA 510(k) Application Details - K992994
Device Classification Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
More FDA Info for this Device
510(K) Number
K992994
Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT, TN 38133 US
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Contact
JEFF COBB
Other 510(k) Applications for this Contact
Regulation Number
874.4250
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Classification Product Code
ERL
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More FDA Info for this Product Code
Date Received
09/07/1999
Decision Date
11/23/1999
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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