Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K843988 |
Device Name |
S.E.T. TUBE |
Applicant |
BFW LABORATORIES, INC. |
10701 RED CIRCLE DR. |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
MICHAEL W WALSH |
Correspondent |
BFW LABORATORIES, INC. |
10701 RED CIRCLE DR. |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
MICHAEL W WALSH |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 10/11/1984 |
Decision Date | 02/21/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|