Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K802444 |
Device Name |
PAPILLOTOME PRODUCT |
Applicant |
MILL-ROSE LABORATORY |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MILL-ROSE LABORATORY |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 10/07/1980 |
Decision Date | 10/23/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|