Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
More FDA Info for this Device |
510(K) Number |
K964548 |
Device Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
Applicant |
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO, FL 33773-4908 US
Other 510(k) Applications for this Company
|
Contact |
CAROL A WEIDEMAN, PH.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 |
11/13/1996 |
Decision Date |
01/17/1997 |
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 |
|