Device Classification Name |
filter, bacterial, breathing-circuit
|
510(k) Number |
K941536 |
Device Name |
BARRIERBAC AND BARRIERBAC S |
Applicant |
MALLINCKRODT MEDICAL |
R.D. #1 BOX 1173 |
HOOK ROAD |
ARGYLE,
NY
12809
|
|
Applicant Contact |
FRANK STECIUK |
Correspondent |
MALLINCKRODT MEDICAL |
R.D. #1 BOX 1173 |
HOOK ROAD |
ARGYLE,
NY
12809
|
|
Correspondent Contact |
FRANK STECIUK |
Regulation Number | 868.5260
|
Classification Product Code |
|
Date Received | 03/30/1994 |
Decision Date | 04/19/1994 |
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
|
|
|