The following data is part of a premarket notification filed by Alba Health Care with the FDA for Alba Dry Burn Dressing.
| Device ID | K850904 |
| 510k Number | K850904 |
| Device Name: | ALBA DRY BURN DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | ALBA HEALTH CARE POST OFFICE BOX 100 Valdese, NC 28690 |
| Contact | Victor H Garrou |
| Correspondent | Victor H Garrou ALBA HEALTH CARE POST OFFICE BOX 100 Valdese, NC 28690 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-05 |
| Decision Date | 1985-04-17 |