Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K970945 |
Device Name |
ANGLED TIP POLYPECTOMY SNARE |
Applicant |
UNITED STATES ENDOSCOPY GROUP, INC. |
9330 PROGRESS PKWY. |
MENTOR,
OH
44060
|
|
Applicant Contact |
GRETCHEN YOUNKER-COHEN |
Correspondent |
UNITED STATES ENDOSCOPY GROUP, INC. |
9330 PROGRESS PKWY. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
GRETCHEN YOUNKER-COHEN |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 03/14/1997 |
Decision Date | 05/07/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|