Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K121007 |
Device Name |
NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 |
Applicant |
DELTA MED SRL |
721 KRISTIN COURT |
WESTMONT,
IL
60559
|
|
Applicant Contact |
HARRY BONTRAGER |
Correspondent |
DELTA MED SRL |
721 KRISTIN COURT |
WESTMONT,
IL
60559
|
|
Correspondent Contact |
HARRY BONTRAGER |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 04/03/2012 |
Decision Date | 12/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|