Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K880487 |
Device Name |
NEOTECH MECONIUM ASPIRATOR (STERILE) |
Applicant |
NEOTECH PRODUCTS, INC. |
9135 ALABAMA AVENUE, SUITE F |
CHATSWORTH,
CA
91311
|
|
Applicant Contact |
THOMAS R THORNBURY |
Correspondent |
NEOTECH PRODUCTS, INC. |
9135 ALABAMA AVENUE, SUITE F |
CHATSWORTH,
CA
91311
|
|
Correspondent Contact |
THOMAS R THORNBURY |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 02/04/1988 |
Decision Date | 05/06/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|