Device Classification Name |
Bur, Ear, Nose And Throat
|
510(k) Number |
K955294 |
Device Name |
SOF - ABRASION BUR |
Applicant |
TREBAY MEDICAL CORP. |
4911 CREEKSIDE DR. |
CLEARWATER,
FL
34620
|
|
Applicant Contact |
DAN H TREACE |
Correspondent |
TREBAY MEDICAL CORP. |
4911 CREEKSIDE DR. |
CLEARWATER,
FL
34620
|
|
Correspondent Contact |
DAN H TREACE |
Regulation Number | 874.4140 |
Classification Product Code |
|
Date Received | 11/17/1995 |
Decision Date | 12/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|