Device Classification Name |
Washer, Cleaner, Automated, Endoscope
|
510(k) Number |
K983017 |
Device Name |
MODIFICATION TO SYSTEM 83 PLUS |
Applicant |
CUSTOM ULTRASONICS |
144 RAILROAD DR. |
IVYLAND,
PA
18974
|
|
Applicant Contact |
FRANK J WEBER |
Correspondent |
CUSTOM ULTRASONICS |
144 RAILROAD DR. |
IVYLAND,
PA
18974
|
|
Correspondent Contact |
FRANK J WEBER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/28/1998 |
Decision Date | 09/22/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|