Device Classification Name |
Container, Empty, For Collection & Processing Of Blood & Blood Components
|
510(k) Number |
K020753 |
Device Name |
DEROYAL SURGICAL, UMBILICUP |
Applicant |
DEROYAL |
200 DEBUSK LN. |
POWELL,
TN
37849
|
|
Applicant Contact |
AUDREY DANIELS |
Correspondent |
DEROYAL |
200 DEBUSK LN. |
POWELL,
TN
37849
|
|
Correspondent Contact |
AUDREY DANIELS |
Regulation Number | 864.9100
|
Classification Product Code |
|
Date Received | 03/07/2002 |
Decision Date | 06/13/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|