| Device Classification Name |
Dressing, Wound, Drug
|
| 510(k) Number |
K931510 |
| Device Name |
GERITREX STERILE SALINE WET DRESSING |
| Applicant |
| Geritrex Corp. |
| 2 E. Sanford Blvd. |
|
Mount Vernon,
NY
10550
|
|
| Applicant Contact |
ANTHONY MADAIO |
| Correspondent |
| Geritrex Corp. |
| 2 E. Sanford Blvd. |
|
Mount Vernon,
NY
10550
|
|
| Correspondent Contact |
ANTHONY MADAIO |
| Classification Product Code |
|
| Date Received | 03/26/1993 |
| Decision Date | 07/13/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|