Device Classification Name |
tubes, vials, systems, serum separators, blood collection
|
510(k) Number |
K192247 |
Device Name |
Steripath Gen2 Blood Collection System |
Applicant |
Magnolia Medical Technologies, Inc. |
200 West Mercer Street |
Suite 500 |
Seattle,
WA
98119
|
|
Applicant Contact |
Gregory J Bullington |
Correspondent |
Magnolia Medical Technologies, Inc. |
200 West Mercer Street |
Suite 500 |
Seattle,
WA
98119
|
|
Correspondent Contact |
John Ray |
Regulation Number | 862.1675
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/19/2019 |
Decision Date | 02/28/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|