Device Classification Name |
Indicator, Biological Sterilization Process
|
510(k) Number |
K111391 |
Device Name |
STERRAD (R) 100NX DUO CYCLE TEST PACK |
Applicant |
ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. |
IRVINE,
CA
92618
|
|
Applicant Contact |
NANCY CHU |
Correspondent |
ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. |
IRVINE,
CA
92618
|
|
Correspondent Contact |
NANCY CHU |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 05/18/2011 |
Decision Date | 09/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|