The following data is part of a premarket notification filed by Alba-waldensian, Inc. with the FDA for Alba Dry Burn Pad.
| Device ID | K852091 |
| 510k Number | K852091 |
| Device Name: | ALBA DRY BURN PAD |
| Classification | Dressing, Wound, Drug |
| Applicant | ALBA-WALDENSIAN, INC. Valdese, NC 28690 |
| Contact | Victor H Garrou |
| Correspondent | Victor H Garrou ALBA-WALDENSIAN, INC. 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 | 1985-05-13 |
| Decision Date | 1985-06-13 |