| Device Classification Name |
Gauze/Sponge, Internal
|
| 510(k) Number |
K962227 |
| Device Name |
PRO-FECT STERILE GAUZE SPONGES |
| Applicant |
| Network Trading Corp. Dba Grand Intl. |
| 7222 Ertel Ln. |
|
Houston,
TX
77040
|
|
| Applicant Contact |
DERICK LI |
| Correspondent |
| Network Trading Corp. Dba Grand Intl. |
| 7222 Ertel Ln. |
|
Houston,
TX
77040
|
|
| Correspondent Contact |
DERICK LI |
| Classification Product Code |
|
| Date Received | 06/10/1996 |
| Decision Date | 08/19/1996 |
| 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
|
|
|