| Device Classification Name |
Indicator, Biological Sterilization Process
|
| 510(k) Number |
K905425 |
| Device Name |
SPORVIEW |
| Applicant |
| Spsmedical Supply Corp. |
| 1250 Scottsville Rd. |
|
Rochester,
NY
14624
|
|
| Applicant Contact |
JACK SCOVILLE |
| Correspondent |
| Spsmedical Supply Corp. |
| 1250 Scottsville Rd. |
|
Rochester,
NY
14624
|
|
| Correspondent Contact |
JACK SCOVILLE |
| Regulation Number | 880.2800 |
| Classification Product Code |
|
| Date Received | 12/04/1990 |
| Decision Date | 03/27/1992 |
| 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
|
| Recalls |
CDRH Recalls
|
|
|