Device Classification Name |
catheters, suction, tracheobronchial
|
510(k) Number |
K862132 |
Device Name |
HCI MECONIUM ASPIRATOR |
Applicant |
HOSPITAL CONCEPTS, INC. |
2701 W. ALAMEDA AVE., SUITE |
406 |
BURBANK,
CA
91505
|
|
Applicant Contact |
PRADIP CHOKSI |
Correspondent |
HOSPITAL CONCEPTS, INC. |
2701 W. ALAMEDA AVE., SUITE |
406 |
BURBANK,
CA
91505
|
|
Correspondent Contact |
PRADIP CHOKSI |
Regulation Number | 868.6810
|
Classification Product Code |
|
Date Received | 06/04/1986 |
Decision Date | 06/19/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|