Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
More FDA Info for this Device |
510(K) Number |
K002828 |
Device Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
Applicant |
XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216-0980 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 |
09/11/2000 |
Decision Date |
10/17/2000 |
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 |
|