| Device Classification Name |
Trap, Sterile Specimen
|
| 510(k) Number |
K902883 |
| Device Name |
TISSUE/POLYP TRAP SYSTEM |
| Applicant |
| Triton Technology, Inc. |
| 2380 Southeast Blvd. |
|
Salem,
OH
44460
|
|
| Applicant Contact |
Z KOLOZSI,MD |
| Correspondent |
| Triton Technology, Inc. |
| 2380 Southeast Blvd. |
|
Salem,
OH
44460
|
|
| Correspondent Contact |
Z KOLOZSI,MD |
| Regulation Number | 880.6740 |
| Classification Product Code |
|
| Date Received | 07/02/1990 |
| Decision Date | 09/12/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|