Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K941728 |
Device Name |
MONOPOLAR COAGULATING POLYPECTOMY SNARE |
Applicant |
ENDOSCOPIC INNOVATIONS, INC. |
MORRIS MEDICAL CENTER |
MONTANA AT FIRST ST. |
MORRIS,
MN
56267
|
|
Applicant Contact |
JOHN L ZENK |
Correspondent |
ENDOSCOPIC INNOVATIONS, INC. |
MORRIS MEDICAL CENTER |
MONTANA AT FIRST ST. |
MORRIS,
MN
56267
|
|
Correspondent Contact |
JOHN L ZENK |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 04/07/1994 |
Decision Date | 06/27/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|