Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
More FDA Info for this Device |
510(K) Number |
K965080 |
Device Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
Applicant |
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS, FL 33410 US
Other 510(k) Applications for this Company
|
Contact |
WILLIAM E ANSPACH, III M.D.
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 |
12/19/1996 |
Decision Date |
01/10/1997 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
EN - Ear, Nose, & Throat |
Review Advisory Committee |
EN - Ear, Nose, & Throat |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|