Device Classification Name |
sterilizer, chemical
|
510(k) Number |
K160903 |
Device Name |
STERRAD 100NX Sterilizer with ALLClearTM Technology |
Applicant |
ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DRIVE |
Irvine,
CA
92617
|
|
Applicant Contact |
JAMIE BYUN |
Correspondent |
ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DRIVE |
Irvine,
CA
92617
|
|
Correspondent Contact |
JAMIE BYUN |
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 04/01/2016 |
Decision Date | 09/26/2016 |
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
|
|
|