Device Classification Name |
Indicator, Biological Sterilization Process
|
510(k) Number |
K023716 |
Device Name |
SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP |
Applicant |
SPS MEDICAL SUPPLY CORP. |
6789 WEST HENRIETTA RD. |
RUSH,
NY
14543
|
|
Applicant Contact |
GARY J SOCOLA |
Correspondent |
SPS MEDICAL SUPPLY CORP. |
6789 WEST HENRIETTA RD. |
RUSH,
NY
14543
|
|
Correspondent Contact |
GARY J SOCOLA |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 11/05/2002 |
Decision Date | 12/05/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|