| Device Classification Name |
Tape And Bandage, Adhesive
|
| 510(k) Number |
K892450 |
| Device Name |
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS |
| Applicant |
| Quinton, Inc. |
| 2121 Terry Ave. |
|
Seattle,
WA
98121
|
|
| Applicant Contact |
RON R DUCK |
| Correspondent |
| Quinton, Inc. |
| 2121 Terry Ave. |
|
Seattle,
WA
98121
|
|
| Correspondent Contact |
RON R DUCK |
| Regulation Number | 880.5240 |
| Classification Product Code |
|
| Date Received | 04/10/1989 |
| Decision Date | 10/11/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|