| Device Classification Name |
Gauze/Sponge, Internal
|
| 510(k) Number |
K890727 |
| Device Name |
NON-STERILE, BULK GAUZE SPONGES |
| Applicant |
| Cypress Medical Products, Ltd. |
| 1202 S. Rte. 31 |
|
Mc Henry,
IL
60050
|
|
| Applicant Contact |
VARUN SONI |
| Correspondent |
| Cypress Medical Products, Ltd. |
| 1202 S. Rte. 31 |
|
Mc Henry,
IL
60050
|
|
| Correspondent Contact |
VARUN SONI |
| Classification Product Code |
|
| Date Received | 02/13/1989 |
| Decision Date | 03/10/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|