Device Classification Name |
Brush, Biopsy, General & Plastic Surgery
|
510(k) Number |
K820259 |
Device Name |
STERILE CYTOLOGY BRUSHES |
Applicant |
AMERICAN ENDOSCOPY, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AMERICAN ENDOSCOPY, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 02/01/1982 |
Decision Date | 03/05/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|