Device Classification Name |
Fab, Rhodamine, Antigen, Antiserum, Control
|
510(k) Number |
K013919 |
Device Name |
TORFLEX TRANSSEPTAL GUIDING SHEATH |
Applicant |
BAYLIS MEDICAL CO., INC. |
5160 EXPLORER DRIVE, UNIT 33 |
MISSISSAUGA, ONTARIO,
CA
L4W-4T7
|
|
Applicant Contact |
KRIS SHAH |
Correspondent |
BAYLIS MEDICAL CO., INC. |
5160 EXPLORER DRIVE, UNIT 33 |
MISSISSAUGA, ONTARIO,
CA
L4W-4T7
|
|
Correspondent Contact |
KRIS SHAH |
Regulation Number | 866.5520
|
Classification Product Code |
|
Date Received | 11/27/2001 |
Decision Date | 02/22/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|