| Device Classification Name |
accessories, cleaning, for endoscope
|
|---|
| 510(K) Number |
K060458 |
|---|
| Device Name |
MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR |
|---|
| Applicant |
| LANGFORD IC SYSTEMS, INC. |
| 141 washington street |
|
east walpole,
MA
02032
|
|
| Contact |
jimmie t johnston |
| Regulation Number | 876.1500
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/22/2006 |
|---|
| Decision Date | 10/12/2006 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Gastroenterology/Urology
|
|---|
| Review Advisory Committee |
General Hospital
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
