Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K061684 |
Device Name |
MEDI-GLOBE ROTA-CUT SPHINCTEROTOME |
Applicant |
MEDI-GLOBE CORPORATION |
110 WEST ORION #136 |
TEMPE,
AZ
85248
|
|
Applicant Contact |
SCOTT KARLER |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 06/15/2006 |
Decision Date | 06/27/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|