Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K070449 |
Device Name |
LUMILOC (TM) SAFETY INTRODUCER NEEDLE |
Applicant |
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. |
586 WEST 500 SOUTH #200 |
SALT LAKE,
UT
84010
|
|
Applicant Contact |
Mark Nelson |
Correspondent |
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. |
586 WEST 500 SOUTH #200 |
SALT LAKE,
UT
84010
|
|
Correspondent Contact |
Mark Nelson |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 02/15/2007 |
Decision Date | 06/14/2007 |
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
|
|
|