Device Classification Name |
accessories, cleaning, for endoscope
|
510(k) Number |
K040883 |
Device Name |
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM |
Applicant |
ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. |
IRVINE,
CA
92618
|
|
Applicant Contact |
NEELU MEDHEKAR |
Correspondent |
ADVANCED STERILIZATION PRODUCTS |
33 TECHNOLOGY DR. |
IRVINE,
CA
92618
|
|
Correspondent Contact |
NEELU MEDHEKAR |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/05/2004 |
Decision Date | 03/15/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|