| Device Classification Name |
Gauze/Sponge, Internal
|
| 510(k) Number |
K950404 |
| Device Name |
LOCKETT MEDICAL CORP. GAUZE |
| Applicant |
| Lockett Medical Corp. |
| Three Richmond Sq. |
|
Providence,
RI
02906
|
|
| Applicant Contact |
DENISE TREACY |
| Correspondent |
| Lockett Medical Corp. |
| Three Richmond Sq. |
|
Providence,
RI
02906
|
|
| Correspondent Contact |
DENISE TREACY |
| Classification Product Code |
|
| Date Received | 01/31/1995 |
| Decision Date | 04/17/1995 |
| 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
|
|
|