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FDA 510(k) Application Details - K002224
Device Classification Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
More FDA Info for this Device
510(K) Number
K002224
Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant
MEDTRONIC XOMED
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216 US
Other 510(k) Applications for this Company
Contact
MARTIN D SARGENT
Other 510(k) Applications for this Contact
Regulation Number
874.4250
More FDA Info for this Regulation Number
Classification Product Code
ERL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/24/2000
Decision Date
12/04/2000
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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