Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
More FDA Info for this Device |
510(K) Number |
K161376 |
Device Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
Applicant |
Grace Medical, Inc.
8500 Wolf Lake Drive
Suite 110
Memphis, TN 38133 US
Other 510(k) Applications for this Company
|
Contact |
William Graham
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 |
05/18/2016 |
Decision Date |
08/25/2016 |
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 |
Y |
Expedited Review |
|