Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K960232 |
Device Name |
ENDOSCOPIC ACCESS DEVICE |
Applicant |
APPLIED MEDICAL TECHNOLOGIES |
6100 WEST CREEK RD. |
SUITE 25 |
INDEPENDENCE,
OH
44131
|
|
Applicant Contact |
KATHY FELTRIN |
Correspondent |
APPLIED MEDICAL TECHNOLOGIES |
6100 WEST CREEK RD. |
SUITE 25 |
INDEPENDENCE,
OH
44131
|
|
Correspondent Contact |
KATHY FELTRIN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/17/1996 |
Decision Date | 03/21/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|