| Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
| 510(k) Number |
K781353 |
| Device Name |
PAPILLOTOME CUTTING SNARE |
| Applicant |
| Cameron-Miller, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Cameron-Miller, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Regulation Number | 876.4300 |
| Classification Product Code |
|
| Date Received | 08/07/1978 |
| Decision Date | 10/10/1978 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|