Device Classification Name |
filter, bacterial, breathing-circuit
|
510(k) Number |
K791307 |
Device Name |
UNIPOR BREATHING CIRCUIT FILTER |
Applicant |
PALL BIOMEDICAL PRODUCTS CO. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
PALL BIOMEDICAL PRODUCTS CO. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.5260
|
Classification Product Code |
|
Date Received | 07/16/1979 |
Decision Date | 08/03/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|