Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K043258 |
Device Name |
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02 |
Applicant |
TELEFLEX MEDICAL |
50 PLANTATION DRIVE |
TALL PINES PARK |
JAFFERY,
NH
03452
|
|
Applicant Contact |
SUSAN KAGAN |
Correspondent |
TELEFLEX MEDICAL |
50 PLANTATION DRIVE |
TALL PINES PARK |
JAFFERY,
NH
03452
|
|
Correspondent Contact |
SUSAN KAGAN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 11/24/2004 |
Decision Date | 12/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|