Device Classification Name |
container, i.v.
|
510(k) Number |
K190305 |
Device Name |
Additive Cap |
Applicant |
International Medical Industries, Inc. |
2981 Gateway Drive |
Pompano Beach,
FL
33069
|
|
Applicant Contact |
Peter Lehel |
Correspondent |
International Medical Industries, Inc. |
2981 Gateway Drive |
Pompano Beach,
FL
33069
|
|
Correspondent Contact |
Peter Lehel |
Regulation Number | 880.5025
|
Classification Product Code |
|
Date Received | 02/12/2019 |
Decision Date | 04/30/2019 |
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
|
|
|