| Device Classification Name |
Indicator, Physical/Chemical Sterilization Process
|
| 510(k) Number |
K895910 |
| Device Name |
STEAMLINE |
| Applicant |
| Propper Mfg. Co., Inc. |
| 3604 Skillman Ave. |
|
Long Island City,
NY
11101
|
|
| Applicant Contact |
PLATKO, PHD |
| Correspondent |
| Propper Mfg. Co., Inc. |
| 3604 Skillman Ave. |
|
Long Island City,
NY
11101
|
|
| Correspondent Contact |
PLATKO, PHD |
| Regulation Number | 880.2800 |
| Classification Product Code |
|
| Date Received | 10/10/1989 |
| Decision Date | 08/22/1990 |
| 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
|
|
|