Device Classification Name |
burr, orthopedic
|
510(k) Number |
K760236 |
Device Name |
BUR, SURGICAL CARBIDE |
Applicant |
CUTTER LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CUTTER LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 888.4540
|
Classification Product Code |
|
Date Received | 07/15/1976 |
Decision Date | 07/26/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|