The following data is part of a premarket notification filed by Alba Health Care with the FDA for Alba Health Care Non-adhering Dressing.
| Device ID | K850241 |
| 510k Number | K850241 |
| Device Name: | ALBA HEALTH CARE NON-ADHERING 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 | 1985-01-22 |
| Decision Date | 1985-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10665973017775 | K850241 | 000 |
| 20665973016492 | K850241 | 000 |
| 10665973016532 | K850241 | 000 |
| 20665973016546 | K850241 | 000 |
| 20665973016553 | K850241 | 000 |
| 20665973016560 | K850241 | 000 |
| 10665973016600 | K850241 | 000 |
| 10665973017157 | K850241 | 000 |
| 10665973017164 | K850241 | 000 |
| 20665973017178 | K850241 | 000 |
| 10665973017188 | K850241 | 000 |
| 20665973016485 | K850241 | 000 |