Device Classification Name |
filter, infusion line
|
510(k) Number |
K905794 |
Device Name |
PALL 3N1 FILTER |
Applicant |
PALL BIOMEDICAL PRODUCTS CO. |
77 CRESCENT BEACH RD. |
GLEN COVE,
NY
11542
|
|
Applicant Contact |
EDWARD A LEMMO |
Correspondent |
PALL BIOMEDICAL PRODUCTS CO. |
77 CRESCENT BEACH RD. |
GLEN COVE,
NY
11542
|
|
Correspondent Contact |
EDWARD A LEMMO |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/27/1990 |
Decision Date | 06/13/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|