Device Classification Name |
Snare, Flexible
|
510(k) Number |
K911482 |
Device Name |
LAPAROSCOPIC SNARE |
Applicant |
UNITED STATES ENDOSCOPY GROUP, INC. |
7123 INDUSTRIAL PARK BLVD. |
MENTOR,
OH
44060
|
|
Applicant Contact |
DEAN SECREST |
Correspondent |
UNITED STATES ENDOSCOPY GROUP, INC. |
7123 INDUSTRIAL PARK BLVD. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
DEAN SECREST |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 04/04/1991 |
Decision Date | 04/22/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|