Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K942068 |
Device Name |
AMERICAN CATHETER SPHINCTEROTOME |
Applicant |
INTL. MEDICAL, INC. |
10061 AMBERWOOD RD. |
FORT MYERS,
FL
33913
|
|
Applicant Contact |
PETER H WETTERMANN |
Correspondent |
INTL. MEDICAL, INC. |
10061 AMBERWOOD RD. |
FORT MYERS,
FL
33913
|
|
Correspondent Contact |
PETER H WETTERMANN |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 04/29/1994 |
Decision Date | 06/24/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|