Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K873461 |
Device Name |
LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) |
Applicant |
MALLINCKRODT CRITICAL CARE |
HOOK RD. |
ARGYLE,
NY
12809
|
|
Applicant Contact |
E WIEGERT,PHD |
Correspondent |
MALLINCKRODT CRITICAL CARE |
HOOK RD. |
ARGYLE,
NY
12809
|
|
Correspondent Contact |
E WIEGERT,PHD |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 08/28/1987 |
Decision Date | 11/06/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|