| Device Classification Name |
Plasma, Coagulation Control
|
| 510(k) Number |
K884854 |
| Device Name |
COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL) |
| Applicant |
| Precision Biologicals, Inc. |
| 11a Pettipas Dr. |
|
Dartmouth,
CA
NS B3B 1K1
|
|
| Applicant Contact |
TONY BEBBINGTON |
| Correspondent |
| Precision Biologicals, Inc. |
| 11a Pettipas Dr. |
|
Dartmouth,
CA
NS B3B 1K1
|
|
| Correspondent Contact |
TONY BEBBINGTON |
| Regulation Number | 864.5425 |
| Classification Product Code |
|
| Date Received | 11/18/1988 |
| Decision Date | 01/30/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Hematology
|
| 510k Review Panel |
Hematology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|