Device Classification Name |
accessories, cleaning, for endoscope
|
510(k) Number |
K061430 |
Device Name |
SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR |
Applicant |
CUSTOM ULTRASONICS |
144 RAILROAD DR. |
IVYLAND,
PA
18974
|
|
Applicant Contact |
LAWRENCE F MUSCARELLA |
Correspondent |
CUSTOM ULTRASONICS |
144 RAILROAD DR. |
IVYLAND,
PA
18974
|
|
Correspondent Contact |
LAWRENCE F MUSCARELLA |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/23/2006 |
Decision Date | 01/12/2007 |
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
|
|
|