Device Classification Name |
sterilant, medical devices
|
510(k) Number |
K991487 |
Device Name |
CIDEX OPA SOLUTION |
Applicant |
ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. |
IRVINE,
CA
92618
|
|
Applicant Contact |
JOHN E FRIND |
Correspondent |
ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. |
IRVINE,
CA
92618
|
|
Correspondent Contact |
JOHN E FRIND |
Regulation Number | 880.6885
|
Classification Product Code |
|
Date Received | 04/28/1999 |
Decision Date | 10/08/1999 |
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
|
|
|