Device Classification Name |
indicator, physical/chemical sterilization process
|
510(k) Number |
K982188 |
Device Name |
STERI-PAK BOWIE DICK TEST PACK |
Applicant |
STERITEC PRODUCTS MFG. CO., INC. |
680 ATCHISON WAY |
SUITE 600 |
CASTLE ROCK,
CO
80104
|
|
Applicant Contact |
LON BRUSO |
Correspondent |
STERITEC PRODUCTS MFG. CO., INC. |
680 ATCHISON WAY |
SUITE 600 |
CASTLE ROCK,
CO
80104
|
|
Correspondent Contact |
LON BRUSO |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 06/22/1998 |
Decision Date | 11/20/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|