Device Classification Name |
indicator, physical/chemical sterilization process
|
510(k) Number |
K102363 |
Device Name |
SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004 |
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 | 08/20/2010 |
Decision Date | 01/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|