| Device Classification Name |
Catheters, Suction, Tracheobronchial
|
| 510(k) Number |
K923098 |
| Device Name |
STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE |
| Applicant |
| Trinity Laboratories, Inc. |
| 201 Kiley Dr. |
|
Salisbury,
MD
21801
|
|
| Applicant Contact |
PARTHA BASUMALLIK |
| Correspondent |
| Trinity Laboratories, Inc. |
| 201 Kiley Dr. |
|
Salisbury,
MD
21801
|
|
| Correspondent Contact |
PARTHA BASUMALLIK |
| Regulation Number | 868.6810 |
| Classification Product Code |
|
| Date Received | 06/25/1992 |
| Decision Date | 09/21/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|