| Device Classification Name |
Gauze/Sponge, Internal
|
| 510(k) Number |
K960523 |
| Device Name |
NHMC DRESSING TRAY |
| Applicant |
| National Healthcare Mfg. Corp. |
| 251 Saulteaux Crescent |
|
Winnipeg, Mb,
CA
R3J 3C7
|
|
| Applicant Contact |
BOB JACKSON |
| Correspondent |
| National Healthcare Mfg. Corp. |
| 251 Saulteaux Crescent |
|
Winnipeg, Mb,
CA
R3J 3C7
|
|
| Correspondent Contact |
BOB JACKSON |
| Classification Product Code |
|
| Date Received | 02/06/1996 |
| Decision Date | 04/04/1996 |
| 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
|
|
|