Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K043284 |
Device Name |
ENDOASSIST |
Applicant |
ARMSTRONG HEALTHCARE LIMITED |
KNAVES BEECH BUSINESS CENTRE |
LOUDWATER |
HIGH WYCOMBE,
GB
HP10 9QR
|
|
Applicant Contact |
PATRICK A FINLAY |
Correspondent |
ARMSTRONG HEALTHCARE LIMITED |
KNAVES BEECH BUSINESS CENTRE |
LOUDWATER |
HIGH WYCOMBE,
GB
HP10 9QR
|
|
Correspondent Contact |
PATRICK A FINLAY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/26/2004 |
Decision Date | 02/25/2005 |
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
|
|
|