| Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
| 510(k) Number |
K920089 |
| Device Name |
MONOPOLAR COAGULATING POLYPECTOMY SNARE |
| Applicant |
| Everest Medical Corp. |
| 13755 First Ave. N. |
|
Minneapolis,
MN
55441
|
|
| Applicant Contact |
DAVID J PARINS |
| Correspondent |
| Everest Medical Corp. |
| 13755 First Ave. N. |
|
Minneapolis,
MN
55441
|
|
| Correspondent Contact |
DAVID J PARINS |
| Regulation Number | 876.4300 |
| Classification Product Code |
|
| Date Received | 01/08/1992 |
| Decision Date | 03/31/1992 |
| 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
|
|
|