Device Classification Name |
endoscopic injection needle, gastroenterology-urology
|
510(k) Number |
K090830 |
Device Name |
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP |
Applicant |
LABORIE MEDICAL TECHNOLOGIES, LTD. |
400 AVENUE D |
SUITE 10 |
WILLISTON,
VT
05495
|
|
Applicant Contact |
BARBARA MORNET |
Correspondent |
LABORIE MEDICAL TECHNOLOGIES, LTD. |
400 AVENUE D |
SUITE 10 |
WILLISTON,
VT
05495
|
|
Correspondent Contact |
BARBARA MORNET |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/26/2009 |
Decision Date | 07/21/2009 |
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
|
Recalls |
CDRH Recalls
|
|
|