| Device Classification Name |
Sterilizer, Dry Heat
|
| 510(k) Number |
K881371 |
| Device Name |
COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE |
| Applicant |
| Cox Sterile Products, Inc. |
| 5115 Mckinney Ave., Suite C |
|
Dallas,
TX
75205
|
|
| Applicant Contact |
COX, D.D.S. |
| Correspondent |
| Cox Sterile Products, Inc. |
| 5115 Mckinney Ave., Suite C |
|
Dallas,
TX
75205
|
|
| Correspondent Contact |
COX, D.D.S. |
| Regulation Number | 880.6870 |
| Classification Product Code |
|
| Date Received | 04/01/1988 |
| Decision Date | 04/13/1988 |
| 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
|
|
|