Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K802505 |
Device Name |
DOUBLE LUMEN TRACHEAL TUBE |
Applicant |
NATIONAL CATHETER CO. DIV. MALLINCKRODT |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
NATIONAL CATHETER CO. DIV. MALLINCKRODT |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 10/15/1980 |
Decision Date | 03/13/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|