| 510(k) Number |
K854290 |
| Device Name |
MEDSURG AMNIOCENTESIS TRAY |
| Applicant |
| Medsurg Industries, Inc. |
| 251 Exchange Place |
|
Herndon,
VA
20170 -4822
|
|
| Applicant Contact |
DONNA COLLIER |
| Correspondent |
| Medsurg Industries, Inc. |
| 251 Exchange Place |
|
Herndon,
VA
20170 -4822
|
|
| Correspondent Contact |
DONNA COLLIER |
| Date Received | 10/25/1985 |
| Decision Date | 01/24/1986 |
| Decision |
Substantially Equivalent - With Drug
(SESD) |
| 510k Review Panel |
Obstetrics/Gynecology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|