Device Classification Name |
sterilizer, chemical
|
510(k) Number |
K162007 |
Device Name |
STERRAD NX Sterilizer |
Applicant |
Advanced Sterilization Products |
33 Technology Dr. |
Irvine,
CA
92618
|
|
Applicant Contact |
Nazanin Yacobi |
Correspondent |
Advanced Sterilization Products |
33 Technology Dr. |
Irvine,
CA
92618
|
|
Correspondent Contact |
Nazanin Yacobi |
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 07/20/2016 |
Decision Date | 02/16/2017 |
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
|
|
|