Device Classification Name |
tube, tracheostomy (w/wo connector)
|
510(k) Number |
K852413 |
Device Name |
LGT TUBE |
Applicant |
MALLINCKRODT CRITICAL CARE |
73 QUAKER RD. |
GLENS FALLS,
NY
12301
|
|
Applicant Contact |
PHILIP E WIEGERT |
Correspondent |
MALLINCKRODT CRITICAL CARE |
73 QUAKER RD. |
GLENS FALLS,
NY
12301
|
|
Correspondent Contact |
PHILIP E WIEGERT |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 06/06/1985 |
Decision Date | 09/05/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|