Device Classification Name |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
|
510(k) Number |
K812685 |
Device Name |
ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE |
Applicant |
ERICKA |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
ERICKA |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 09/22/1981 |
Decision Date | 09/29/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|